Oct Nov 2020 Issue

NGIMES - DIGITIZATION PLATFORM FOR PHARMA MANUFACTURER

PM&T_OCT-NOV.-2020

machines & technology

Vol - 15 Issue - 3 October - November 2020 PUBLISHER & EDITOR Harjit Singh Dhaul

Dear Pharma Pals,

Editorial Office Global Vision 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101 E-mail:pharmamnt@gmail.com

With globalization, urbanization, and environmental change; ingenious infection flare-ups and epidemics have become worldwide dangers requiring an aggregate reaction. More than 150 countries are in the race for the development of the vaccines, including India. Everybody is putting a sharp eye for the COVID-19 immunizations or vaccine to come out from the pandemic.

Advertisement/Circulation/ Subscription enquiries: Tel: 28701520 Fax: 28701848 Mobile: +91 93 24 577012 E-mail:info@pharmamachines.com Website: www.pharmamachines.com

Therefore, a robust, risk-based environment monitoring program is required to provide sufficient information to manufacturer and regulator to demonstrate that the aseptic processing environment is operating in adequate control and ensure end-product meets predefined critical quality attribute.

The pandemic has made a phenomenal impact on the industrial world where the supply chains have been adversely affected. The Pharma Industry has been at the forefront as it was their role that came under the spotlight. We have seen that a lot of meaningful action that has been taken as things were moving at a snail speed before have suddenly picked up pace in the efficient implementation and execution.

All rights reserved.

Reproduction in any manner is prohibited.

PHARMA Machines & Technology takes no responsibility for validity of claims in advertisement and articles published.

Printed & Published by: Harjit Singh Dhaul on behalf of Global Vision and printed at Hariom Printers, C/70, Akurli Industrial Estate, Akurli Road, Kandivali East, Mumbai 400 101, and published at 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101. Editor Harjit Singh Dhaul.

As such the Attachi System has been deploying the MES solutions in the pharma industry for the last 14 years. The best approach is to plug-in or integrate all the PLC's and ensure that the data is captured in real-time, in other words, we implement the IIOT (Industrial Internet of Things) first.

EDITORIAL ASSISTANT Ravlin Kaur

In this context will highlight SOP's insight, its importance from a regulatory and organization point of view. Earlier, SOPs were usually not followed or written as per the standard; over a period, there had been a tremendous change in SOP and its design format. The perfect and effective written SOP is also a part of achieving the goals.

STAYSAFE STAYSHEALTHY.

Harjit Singh Dhaul

CONTENTS

COVER DESIGN BY: UNIEKORN ADVERTSING Email: jp@uniekorn.com

Exclusives 14

Publisher & Editor

Exclusives

Preview

Standard Operating Procedure (SOP) -

Pharma Pro&Pack CPHI China Achema 2022

An unsung hero of pharmaceutical industry

30

Review

SOP - Common Errors SOP - Past / Present / Feuture

42

Data Integrity By Design Data Integrity- Manufacturing Systems (MES) For Pharma Companies Ai, Robotics – Applications In Pharmaceuticals And Bio-pharmaceuticals

Arab Pharma Expo

46

In focus Liquid Dose Packaging

Interview Digitization Platform for Pharma Manufactures

48 49 50

47

Regulars 24

INDIA PHARMA 8 GOBAL PHARMA 10 DID YOU KNOW? 12

India Pharma CO IM VID-1 PA 9 CT

News & Updates

Over 100 million Sputnik V vaccine produced by Hetero in INDIA The pharma firm through its subsidiary Hetero Biopharma intends to start the production of Sputnik V in the beginning of 2021.According to the second interim data analysis by Gamaleya Center and RDIF, the Sputnik V vaccine demonstrated 91.4% efficacy rate in the evaluation carried out 28 days after administering the first dose. The analysis was announced on November 24.The uniqueness of the Russian vaccine lies in the use of two different vectors based on the human adenovirus, which the makers claim, allows for a stronger and longer-term immune response. Currently, Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India.

Govt launches 'Mission Covid Suraksha' to help accelerate vaccine candidates The government has launched 'Mission Covid Suraksha' to help accelerate the development of approximately 5-6 vaccine candidates and ensure that these are brought closer to licensure and introduction in the market, the Department of Biotechnology. The mission envisages Covid-19 vaccine development with end-to-end focus from preclinical through clinical development and manufacturing and regulatory facilitation. "Government of India announced the third stimulus package of Rs 900 crore for the Mission Covid Suraksha- the Indian Covid-19 Vaccine Development Mission. This grant will be provided to the Department of Biotechnology for research and development of Indian Covid-19 vaccines. A total of 10 vaccine candidates have been supported by the DBT so far in both academia and industry. As on date, five vaccine candidates are in human trials, including the Russian Vaccine Sputnik-V, with at least three more in advanced stages of preclinical to enter human trials shortly.

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PHARMA machines & technology

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Phase-3 trial of Bharat Biotech's Covaxin commences in AIIMS The phase-three human clinical trial of indigenously developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS here on Thursday with Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose. Dr Srivastava was the first one to receive the shot, which would be given to around 15,000 volunteers at the AIIMS over the next few days. The first dose of 0.5 ml intramuscular injection was given to four volunteers. They were under observation for two hours and will be monitored for the next few days. The safety and immunogenicity data of the phase one and two trials were submitted to the central drug regulator. The Hyderabad-based firm, while applying for phase-three trial, stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported.

Zydus Cadila to apply for Phase-3 trials in December, hopes to launch vaccine by March The Ahmedabad-based drug maker will submit the results of its phase-2 trials next week, which "will ascertain the safety, dose and efficacy of the potential vaccine".

Subsequently, Zydus will apply for phase-3 trial which it plans to conduct on 39,000 participants in December. "If all goes well, the company expects to introduce the vaccine

by March next year. Zydus has conducted phase-2 trials on 1,000 participants.

Preliminary results show that it is safe as no safety concerns have been observed so far, people tracking the trials said. Zydus' vaccine technology centre (VTC) has in place the facilities for this, people aware of the matter said. The company is also exploring collaborations to make the vaccine available on a larger scale.

Global Pharma

CO IM VID-1 PA 9 CT

News & Updates

AstraZeneca COVID-19 vaccine shows 90 percent efficacy AstraZeneca informed that its COVID-19 vaccine candidate could be around 90 per cent effective without any serious side effects.

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19.

An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. Company will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval.

Clinical trials are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the company expects to enrol up to 60,000 participants globally.

AZD1222, given as a half dose, followed by a full dose at least one month apart, showed vaccine efficacy of 90 per cent while it showed 62 per cent efficacy when given as two full doses at least one month apart The company is making rapid progress in manufacturing with a capacity of up to three billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.

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UK government secures additional 2 million doses of Moderna COVID-19 vaccine The UK government has signed a deal for a further 2 million doses of Moderna's promising vaccine candidate, bringing the total to 7 million doses for the UK. UK now has access to enough doses of Moderna's vaccine candidate for around 3.5 million people. To be approved for use in the UK, the Moderna vaccine must meet the strict standards of safety and effectiveness of the independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). If it is approved, 7 million doses could start to be delivered to the UK as early as spring 2021 - the same timetable to other countries in Europe. The UK now has access to a total of 357 million doses of vaccines from 7 different developers Anti-depressant repurposed to treat childhood cancer A new study has found that a commonly prescribed anti-depressant may halt growth of a type of cancer known as childhood sarcoma, at least in mice and laboratory cell experiments. The findings, from researchers at Karolinska Institutet in Sweden and MD Anderson Cancer Centre in Texas, ignite hope of novel treatment strategies against this disease. The study examined commonalities between two large groups of cell surface receptors, the so-called G protein-coupled receptors (GPCRs) and the receptor tyrosine kinases (RTKs). GPCRs are targeted by more than half of all developed drugs to treat conditions such as allergies, asthma, depression, anxiety and hypertension, but have so far not been widely used to treat cancers.

CO IM VID-1 PA 9 CT

DYK

Facts & Figures

DID YOU KNOW? India's pharmaceutical market posts 10% growth in October Indian pharma sector can grow to $ 65 billion industry by 2024 Metformin Hydrochloride extended-release tablet is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes mellitus..

First batch of Sputnik V vaccine to arrive in Kanpur medical college for Phase 2, 3 trials.

Granules India gets US FDA approval for Penicillamine Capsules.

Dr Reddy's and the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.

Biological E gets DGCA nod to begin the next phase of trials for its COVID-19 vaccine The Union health ministry has already initiated a cold chain augmentation plan to address the additional cold chain space required for the vaccine..

E-pharmacies set to tap 70 mn houses by Fy2025 Phase I PLI scheme for bulk drugs gets 215 applications from 83 firms Rhizen Pharma gets USFDA approval for Phase I trials of COVID-19 drug862 human cases of influenza A(H5N1) have been reported to WHO since 2003 Healthcare workers, people aged above 65 will be given priority for COVID vaccine Merck KGaA signs deal with Artios Pharma for cancer drugs research COVID-19 vaccine: WHO aims to distribute 500 million doses via COVAX scheme in 2021

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October - November 2020

Exclusive

Pharma 4.0

Gurmeet Singh Pharma Networks - Pharma Consultant

THE TIME HAS COME

The world has in the last one year, witnessed have today, over 100 vaccine candidates in the biggest disruption unprecedented in different stages of development and a significant h i s t o r y. T h e p a n d e m i c h a s m a d e a number of them in phase 2 and phase 3 trials. phenomenal impact on the industrial world where the The time has indeed come for the Pharma Industry to make a swift supply chains have been change by making use of the technology available whether it be the adversely affected. The application of AI for the drug discovery processes or the use of Pharma Industry has been at robotics in drug substance handling and manufacturing to provide the forefront as it was their the much-needed safety to the humans and at the same time ensure role that came under the that there is zero chance of contamination arising due to the human spotlight. We have seen that a factor in the manufacturing process. lot of meaningful action that has been taken as things were moving at a snail speed The first part of a series of articles on the Pharma before have suddenly picked up pace in the industry here is to highlight the role of AI in efficient implementation and execution. These changing the paper logs to digitization and quantum strides were very much required to monitoring on a real-time basis, in compliance make the industry provide solutions today for with the regulatory authorities cannot be the issues of tomorrow‌. could we have ever overemphasized but it needs to be understood as imagined the development of a vaccine in such a basic requirement of pharma industry working a short period where a new vaccine can take going forward. anywhere upwards of 8 years. Globally we

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October - November 2020

Exclusive

Pharma 4.0

“Pharma 4.0 is a framework for adapting digital strategies to the unique contexts of pharmaceutical manufacturing. In practical terms, it means more connectivity, more productivity, simplified compliance, and the marshalling of production information to respond to problems as they emerge” – ISPE (International Society for Pharmaceutical Engineers)

The above is by no means is an exhaustive list of challenges but it spells a game-changer strategy that integrates quality into manufacturing with machines and technology as enablers with reduced or zero human intervention which will ensure cGMP compliance as laid down by the regulators.

The Pharma Industry is experiencing a major disruption in its various fronts and some of these areas are as under:

in the growth of the pharma industry and all this has been possible due to the change agents, the stalwarts in the industry who could envision beyond the times and in their brainstorming sessions with the technology solution providers who together, worked upon to address and come with a workable solution now known as Pharma 4.0

We have noticed major transformation taking place

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Product differentiation

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Tremendous progress in Biotech, Genetics, Cell Therapy etc

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Treatment of rare and neglected diseases

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Geriatric population and their differing medicinal needs

The Pharma 3.0 was the process of Computerization and Connectivity and the journey from Pharma 3.0 to Pharma 4.0 included the following steps:

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Mental health issues on the increase

•

Visibility- seeing what is happening

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Customised medicines

•

Understanding why it is happening

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Pollution Challenges: Synthetics Vs Green Chemistry and enzymatic steps

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Predictive – what will happen?

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How an autonomous response can be achieved

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Ever-increasing stringent quality parameters and stricter FDA norms

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Supply Chain disruptions and need for cold chains to ensure product integrity

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Challenges like pandemic and virus mutation demanding continued vigil

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AI application in the medical domain to fast track drug discovery at reduced costs

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DATA INTEGRITY BY DESIGN We have been talking about Quality by Design – QBD for some years now and now is the opportune time to discuss Data Integrity by Design. In other words, the platform has changed from application integrity to data integrity. The systems today are moving to a design data and system architecture in which data integrity is intrinsic and part and parcel of the interacting collaborative platforms – interacting

October - November 2020

Exclusive

Pharma 4.0

within various facets with the manufacturing space on the production floor seamlessly and transparently which facilitates online monitoring on a real-time basis.

DATA INTEGRITY- MANUFACTURING SYSTEMS (MES) FOR PHARMA COMPANIES The changing dynamics of drug substance supplies and the emergent need of medicines during the pandemic made some feel that the USFDA inspections became a little lenient. However, there is a growing need to go in for compliance at every stage to ensure that the right drug product reaches the patient despite all the compulsions and emergencies arising due to the sudden supply chain disruptions. There is a growing need for IT system solutions which minimize human error or rather does away with human intervention and captures digitally and in real-time basis every event in the raw material procurement, from raw material testing to dispensing, formulating of the drug substance, packing in all the stages namely primary, secondary and tertiary and thereafter stock tracking and warehousing and right up to the last mile to ensure drug product integrity.

We find that the next big opportunity lies in the Pharma and Chemical industry. The Pharma industry on a worldwide basis has been a bit slow to implement such solutions which require allocation of funds and the decision has been delayed all this while. The situation as it stands, we have seen for ourselves how the revenues have been adversely impacted for the Pharma companies across the globe when there have been deviations and violations in cGMP compliances and companies have received import alerts and warning letters resulting in major revenue loss for substantial periods.

To address these aspects, we today find a large number of IT and data solutions companies focusing their attention on this opportunity for digitization and incorporating system solutions in the manufacturing and distribution processes to address the requirements of USFDA, EDQM, and other like regulatory authorities to ensure compliance with the regulations.

Some of the significant players offering the IT

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systems solutions are Schneider Electric, Lighthouse Systems, Emerson Electric Co., Pharma MES Berlin, General Electric Company, ABB Ltd, Siemens AG, Rockwell Automation, Werum IT Solutions GmbH, SAP SE, Dassault Systems, ATS Global, Atachi Systems & Honeywell.

Among the top global MES players listed above, Atachi systems is helping Indian pharma companies in succeeding in Pharma 4.0 journey with a tailored Next Generation MES solution (NGIMES).

We do find Indian companies also have sprung up in this space and one such name with a difference is Samvardhana Motherson Health Solutions (SMHS)– the healthtech arm of the auto-ancillary giant Motherson Group which has made an entry in the recent past and are providing configurable and customized IT solutions for healthcare like the elogbook, eBMR, centralized data systems, stocktracking and warehouse management etc wherein they have competitive prices in comparison to some of the international names mentioned above. The emphasis is to replace paper and human intervention or else substantially reduce the incidence of human error creeping in the pharma manufacturing processes with digital technology platforms and further ensuring data integrity and compliances.

Performing Remote Audits During the Pandemic During the COVID-19 pandemic, many of our planned on-site audits have given way to remote desktop audits. Each regulatory agency has its guidelines, but across the board, they all rely on the fundamental principle of a risk-based approach to compliance. As part of the audit preparation, it is important to ensure that all involved parties have suitable and compatible technological means in place, as tools and technology may vary considerably across organizations. A proper checklist may be prepared and shared in advance with minimum requirements, such as Internet upload and download speeds, screen sharing on a need basis to facilitate the audit process.

Therefore, we see that during the pandemic even the audit process can be facilitated by the use of technology and the same needs to have the

October - November 2020

Exclusive

Pharma 4.0

following: • Videoconferencing facility • Web-based meeting systems with screen sharing capability • Teleconferencing in addition to emails • Secure file share systems • ‘Read only' remote access to automated systems, such as electronic QM – quality management systems e.g to view (SOPs) - standard operating procedures, deviations, electronic batch records etc AI, Robotics – applications in Pharmaceuticals and Bio-pharmaceuticals The artificial intelligence pioneers developed machines that could think and reason like humans.

The rapid growth in computing power and memory storage, an unprecedented wealth of data, big data, and the development of advanced algorithms led to substantial breakthroughs in Artificial Intelligence. AI

USD 800 Million to over USD 2 Billion and in addition, it requires many years of sifting various compounds and at times starting from approximately 10000 compounds and then coming down to one commercially viable efficacious drug substance for human use. Therefore, considering the substantial costs and resources, and a low success rate provides an efficient alternate in AI and its application in exploiting known drugs and thereby repurposing, etc.

'Network medicine'- it is appropriate to make a mention of Network Medicine here which means science that combines principles and approaches from systems biology and network science in trying to understand the causes of human diseases and find and develop new treatments. While this becomes a bit technical for a layman reading this article but the application of AI to this aspect will have tremendous benefits to unravel the secrets and come to a desirable solution from a large number of permutation and combinations in the entire drug discovery and alternate application. For sure the knowledge of the interplay between drug targets and human diseases facilitated by AI algorithms can provide clues for possible drug repurposing in maybe in an economical way.

Pharma 4.0 Solutions Plug & Produce Vertical integration through standardized interfaces between MES, automation, and control systems – which is a fundamental prerequisite for implementing various Pharma 4.0 solutions.

Enterprise Manufacturing Intelligence (EMI)

applications today cover diverse fields like computer vision, voice recognition, language understanding, and digital pathology data analysis. Therefore, there lies an immense opportunity for AI in revolutionizing drug discovery by extracting hidden patterns, sequencing, and evidence from biomedical data.

Today the pharmaceutical companies including some start-ups have used AI for drug discovery and development.

It is a well-known fact that the process of drug discovery or researching a New Chemical Entity (NCE) involves resources which have gone up from

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Translate production data into usable information for decision-making and improved processes.

Smart Devices Connect and integrate mobile, and networked devices – making the right information available at the right time and place.

Pharma 4.0 – a way forward The world has witnessed now especially in this pandemic, that the importance of the Pharmaceutical industry and is going to increase as we go further. There is going to be a paradigm shift

October - November 2020

Exclusive

Pharma 4.0

in IIoT and for sure the Pharma industry stands to benefit many times over and therefore the Resources Information Systems companies which have done •Digitization •Holistic Value Network already or do it now will be the •Work Force 4.0 •Integration and Traceability differentiating factor between - Available and Qualied the companies of the future and 'also run' ones. IIoT technologies Culture Organization and will enable manufacturers to get •Communication Processes a 360-degree view of their plant •Decision Making •Holistic Control Strategy •ICH Holistic Control Strategy operations on a real-time basis •Life Cycle Management •Life Cycle Management with the ability to drill down to any level of detail at any stage of Data Integrity by Design Source: ISPEs Digital Maturity Model 4.0 product development and manufacturing. Mind you, all this from the earlier blockbuster drugs, from the earlier would be available at a tap of the screen or as they mass production to the advent of customized and say on pressing of a button, of course, the buttons specialized drugs to a smaller set of patients which have now been replaced by flat screens and only a will in other words mean more and more effective tap is required now. solutions to the patients ailment.

Pharma 4.0 - Digital Maturity Model

In summary, we can say that Pharma 4.0 is a step in the direction of providing the industry with smart solutions, the changing of paper logs to the glass which means digitization which will become inevitable and necessary for enabling seamless data exchange across the entire pharmaceutical supply chain. This will mean the interconnectivity of people, product and processes will get integrated by the IIoTthe Industrial Internet of Things – The pharma and healthcare industry has been slow in getting into this space and now out of various factors of big data and need to have faster solutions at lower costs and lesser time would be the compulsions which will make the Pharma Industry get into IIoT and reap the benefits in a really big way. The analytics and the assistance in new drug discovery would require the Pharma industry to make much-needed investments

The subsequent articles in this series on Pharma 4.0 would focus on the following aspects: • Robotics in Pharmaceuticals – safety and contamination concerns • Data Integrity and cCGM Compliance and Regulatory Audits • Drug Repurposing – a solution that needs to be looked at • Reshoring a Nation's API and Pharmaceutical Production – 'Reverse Swing' • Pandemic and Supply Chain Disruption - Digital route to deliver Covid Vaccine in India. https://www.thelancet.com/JOURNALS/ LANDIG/ARTICLE/PIIS2589-7500(20)30192-8/FULLTEXT https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474498/ https://web.uniroma1.it/stitch/node/5613

About author: Mr. Gurmeet Singh is Director Pharma Networks - a veteran for over 30 years in the Indian Pharmaceutical Sector. He worked with some of the best Pharma companies at the decision-making levels in companies like Ranbaxy, Wockhardt-Swiss and Ireland, Orchid Pharma, and Midas GmbH. In 2018 he worked as a Pharma Development Consultant with DNDi - Drugs for Neglected Diseases initiative - a Geneva-based R&D organization. Mr. Singh is currently associated with Samvardhana Motherson Health Solutions Limited as Business Development Manager. Mr. Singh is a Bachelor of Law (LL.B), a Post Graduate in Management Studies, and a Post Graduate Diploma in Intellectual Property Rights Law. His coordinates are gurmeetsingh144@hotmail.com and gurmeetsingh144@gmail.com

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October - November 2020

Pharma 4.0 (eBMR/IIOT/eLogBooks)

Mr. Krishna Balachandran - Head of Business Development for Atachi systems

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October - November 2020

Interview

Pharma 4.0 (eBMR/IIOT/eLogBooks)

Why the Indian pharma companies need to digitize customers.

Q. their operations or move to the Pharma 4.0?

What is so unique about Atachi systems and why A. Right now, the Indian pharma market is under Q. do you think, Atachi is a perfect fit for Indian the highest pressure because of the following pharma companies? reasons: A. We are bringing 14 years of global pharma I. Emerging global generic drug exports to the developed countries

manufacturing digitization expertise to Indian pharma companies. It distinguishes us from the local MES solutions providers. Atachi has worked with several top global pharma manufacturing companies who have used the other MES platforms and struggled to get the value out of these MES platforms; hence we call them legacy platforms. Atachi NGIMES platform has eliminated all the pain points that companies are struggling with legacy platforms. Our platform is the only MES solution entirely built on SAP HANA platform that leverages Big Data analytics and AI, which need tomorrow's business. Because of these reasons, Atachi systems has been listed as TOP Global MES platforms by several research firms in the last few years, repeatedly.

ii. if we do not ensure that our manufacturing processes are compliant with the FDA regulations, Indian pharma companies will lose the market opportunities, which is multi-billion dollars. iii. The FDA Process is getting stringent every day, and FDA compliance will be enforced for all pharma companies exporting to the developed countries. iv. Compliance is the only thing that will let you to export drugs to these countries v. Warning letters are very expensive, which can cause product recalls, plant shutdowns, etc

Q. A.

What are Atachi solutions offerings for Pharma 4.0?

b. In the second phase, we deploy the MES solution, which is also called as EBMR (Electronic Batch Manufacturing Record), where all the manufacturing processes are digitized end-toend. It will eliminate human errors, and once again, the data integrity issues are resolved.

Q. A.

Given that you are offering so many modules, are you charging the customer for all these modules?

c. At every stage of the processes, we capture the electronic signatures of the associates and generate the real time alerts via SMS and email for any process deviations and ensure that the only qualified batches are shipped out to the

b. Let me give an example, one of our customers was using a legacy MES platform and paid a few hundred thousand dollars to customize and integrate their MES platform with their ERP

Q.

Let us say if an Indian pharma company received an FDA or Compliance warning letter how quickly Atachi can help? What is your approach?

A.

We are the End-To-End Manufacturing Digitization Platform company helping the pharma manufacturers to get them on to the Pharma 4.0 journey and realize complete business agility (quickly and cost-effectively) for their customers with real-time insights. As part of our platform, we offer EBMR, eLogBooks, DMS, CAPA, IIOT, TMS, Supplier quality management, Real-time analytics, Mobility, big data, and AI at a single license cost. Users don't need to pay separately for each functionality; everything comes as a single package in a USE-AS-NEEDED approach.

We have been deploying the MES solutions in the pharma industry for the last 14 years. The best approach is to plug-in or integrate all the PLC's and ensure that the data is captured in real-time, in other words, we implement the IIOT (Industrial Internet of Things) first. This deployment typically takes 10-12 weeks, in this phase we capture the data in real-time and ensure that there are no data integrity issues with the process data.

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No, Absolutely not! We are very inexpensive; On average, we charge 1/4th of top global MES platforms.

October - November 2020

Interview

Pharma 4.0 (eBMR/IIOT/eLogBooks)

systems. When we implemented our solution, that is natively built in SAP HANA platform, our total MES solution costed the customer 1/6th of their (prior MES -ERP) integration cost, not the licensing cost or implementation cost. We deployed the entire solution 1/6th of what they paid just for (MES-ERP) integration. Our complete solution is much cheaper because we built everything on modern technology, and you do not need any additional hardware/server or middleware. So, our TCO is much lower than anyone else. are the other unique features that will make Q. What you standout or go-to-the-solution-provider?

We are proud to say that our solution is highly A.scalable and seamlessly integrates with on-

hand-in-hand and provide data analytics on where they are losing quality, availability, and throughput, etc. For example, we worked with one of the top pharma company in the US; They implemented our Atachi NGIMES -IIOT solution and uncovered the 10% of hidden factory by closely working with us. What is the benefit? They are able to save 200 to 300 Million dollars, bottom line by improving the availability, quality, and throughput.

Q. A.

We will start with an initial meeting with customer, followed by factory visit and then we do a POC for one production line. We do it completely free; they do not need to pay any implementation or product cost. They can experience the product and if they are satisfied, we can go ahead and do the complete implementation for the factory, based on what the customer needs EBMR, IIOT, DMS, QMS etc.

There are no hidden costs for all these products.

The entire platform is available for customer.

premises, cloud, and hybrid third party applications. Our implementation timelines are typically down to 50% - 65% less than the legacy MES platforms' deployment times. Atachi NGIMES platform saves a significant amount of time and effort for validations of MES applications for pharma manufactures.

Q.

I heard from Indian pharma community, when they are committed to deploy MES systems, they do not get much ROI? Is it true?

A.

This statement is true to some extent. Actually, we have a lot of legacy systems in foreign markets. These legacy systems take lot of time, effort, and money to deploy because these legacy MES systems need tedious installations, validations, and expensive post go-live support.

When we talk about Indian pharma, a lot of the MES solutions are point solutions, which means they provide piece by piece functionality or partial functionalities. These solutions provide quick relief, and many times seemed to be cheaper, but customers end up with a lot of integration and quick upgrade costs. Also, these solutions do not give customers a holistic view of manufacturing.

The end result is still data integrity and compliance problems unresolved, even after 2 to 3 years of journey. Hence a lot of Indian pharma manufacturers are frustrated with these legacy systems and point solutions. Atachi systems solution is different; Our MES is built on modern technology and provides a holistic view of the manufacturing. We also work with the customers,

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What are the typical steps for a pharma company to implement your MES solution?

about eLogBooks for Pharma manufacturers?

Q. How Do you provide that along with other solutions?

We do not charge the customers for the A.eLogBooks.

If some Pharma companies need

October - November 2020

eLogBooks, then they can reach out to Atachi systems! It is completely free. The only thing you need to pay a one-time cost for customization and implementation.

Exclusive

Standard Operating Procedure

STANDARD OPERATING PROCEDURE

An unsung hero of pharmaceutical industry

Dhaval Surti

STANDARD OPERATING PROCEDURE, popularly known as SOP, is probably an essential document in the pharmaceutical industry and the most neglected documents compared with the other necessary documents. The Quality Management Systems documents such as Deviations, CAPAs, Change Controls, Effectiveness Checks, and Risk Assessments are considered prominent documents. Such prominence is usually not given to SOPs. In this context will highlight SOP's insight, its importance from a regulatory and organization point of view. Earlier, SOPs were usually not followed or written as per the standard; over a period, there had been a tremendous change in SOP and its design format. The perfect and effective written SOP is also a part of achieving the goals.

30 PHARMA machines & technology

A Standard Operating Procedure (SOP) is a set of written instructions that documents employees follow a routine or repetitive activity in an organization. As industry experts, often fail to recognize that the mother of all evils is tendency to forget to follow SOP. In the pharmaceutical industry, the SOP activities begin from entering the premises, every internal action, and even how to exit the premises.

A typical Pharmaceutical Industry has an average of 400- 1300 SOPs. .... One must think that all procedures laid down, the industry must follow 100% correctly for smooth functioning. Unfortunately, it is not always true and the reason being the SOPs are not given the due prominence it deserves.

October - November 2020

Exclusive

Standard Operating Procedure

Breaking rules in social life creates some thrill to many individuals; many employees achieve the same hidden bliss by not following SOPs. Some old operators/supervisors even take pride that they don't need any SOP to do their task and think they are perfect for executing the given task. Also, sometimes unintentional violation of SOP is also observed which may be due to multiple factors and human error.

However, this is not good for the health of any organization. Rules, regulations, and SOPs help the operation run smoothly and as intended to achieve the target required from the equipment, process, or individuals.

WHY IS SOP REQUIRED? SOP requires for almost all the activities processed in a pharmaceutical company. The general list of SOPs activities follows.

• To define a procedure for activities performed at the company site (manufacturing, cleaning, material handling, etc.)

• To operate machine / instrument / equipment/ utility • To lay down policies (HR, entry-exit, health policies) • To define systems and how to work with the system • To handle documentation (change control, deviations, CAPA, batch records, logbooks)

c) Indicate potential data integrity issues d) Indicates the operation is not performed as per its validation and may result in process failure WHAT GUIDANCE SAYS ABOUT SOPs AND IMPORTANCE OF SOP TRAINING? 21 CFR 211 SUBPART F PRODUCTION AND PROCESS CONTROL Sec. 211.100 WRITTEN PROCEDURES, DEVIATIONS (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess. Such procedure shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b) Written production and process control procedure shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedure shall be recorded and justified.

Sec. 211.25 PERSONNEL QUALIFICATIONS

• One of the main reasons for Form 483 observations issued by FDA is that "SOPs are is not rigorously followed."

(a) Each person engaged in manufacture, processing, packing or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform assigned functions. Training shall be in particular operations that the employee performs and in current good manufacturing practice (including current good manufacturing practice regulations in the guidance and written procedure of 21 CFR 211 regulations) as they relate to employee's functions.

• Ignoring or not following SOPS is like:

Eudralex Annex-1

• Any many more reasons.

W H Y I S S O P I M P O R TA N T ? W H AT I S REGULATORY IMPACT? Though SOPs state as a simple document, it is an essential procedure in the Pharma Industry.

Regulators are very serious about observations; it is observed the employees do not follow site procedure

a) Not doing things the way it design with compliance.

Good Manufacturing Practice Medicinal Products for Human and Veterinary Use:

b) Indicates that all activities at the site are fraudulent.

It has emphasized on word 'Procedure' for all operations described in guidance and mentioned to have procedures defined and should be followed.

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483s Related to SOP in 2018 to 2019 Reference Number

Short Description

Long Description

Frequency

21 CFR 211.22(d)

Procedures not in writing, fully followed

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***

215

21 CFR 211.100(a)

Absence of Written Procedures

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, ***

108

21 CFR 211.113(b)

Procedures for sterile drug products

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***

79

21 CFR 211.198(a)

Procedures to be written and followed

Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***

32

21 CFR 211.80(a)

Procedures To Be in Writing

Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***

19

21 CFR 211.100(b)

Procedure Deviations Deviations from written production and process control Recorded and Justified procedures are not [recorded] [justified]. Specifically, ***

21 CFR 211.100(a)

Approval and review of procedures

Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit]. Specifically, ***

8

21 CFR 211.125(f)

Procedures Written and Followed

Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed].

Specifically, ***

7

21 CFR Manufacturing 211.186(b)(9) Instructions and Specifications

The master production and control records are deficient in that they do not include complete [manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special notations] [precautions]. Specifically, ***

7

21 CFR 212.30(b)

Equipment procedures

You did not [implement procedures] [document your activities in accordance with your procedures] to ensure that all equipment is [cleaned] [suitable for its intended purposes] [properly installed, maintained, and capable of repeatedly producing valid results] that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.

Specifically, ***

21 CFR 211.130

Procedures are written, Procedures designed to assure that correct [labels] [labeling] and followed [packaging materials] are used for drug products are not [written] [followed]. Specifically, ***

14

7

5

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations

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WHAT SHOULD BE CONTENT OF SOP?

Example of short and long instruction

The contents of SOP usually remain the same irrespective of formulation type, whether it is oral solids, liquids, injectables, external preparations, Etc.; however, if the processes change and so the writing of SOP content. Sometimes some minor variations can be seen between company to company - the usual content of SOPs.

1. Long Instruction

• Responsibilities

Take cleaned filling needles, pre-gassing needles, and post gassing needles. Take silicon tubing and clean by passing WFI for not less than 1min. Connect the silicon tubing to the needles and post gassing needle and again rinse the silicon tubing with needle and post gassing needle by passing WFI. Dry the parts with 0.2 µ filtered compressed air and cover the open ends with bio breathable paper. Keep filling needles, gassing needles and post gassing needle connected with silicon tubing in the SS tray.

• References

2. Short Instruction

• Steps to Follow in the sequence they actual process

a) Take cleaned filling needles, pre-gassing needles and post-gassing needles.

• Precautions

b) Take silicon tubing and clean by passing WFI for not less than 1min.

• Purpose • Scope

• Notes

c) Connect the silicon tubing to the needles and post gassing needle and again rinse the silicon tubing with needle and post gassing needle by passing WFI.

• Explanation of complex systems • Parameters, limits, values • Many more What is the writing method of sop?

Perfect written SOP with steps in an exact sequence is easy to follow and avoids procedural deviations SOP must be instructive and directive.

Use simple sentences and avoid complex English grammar or complex terminology (the reader may not be an expert in English, especially at operator level) Always write SOPs in an Active voice. The supervisor should check the final written SOPs. The detailed SOPS does not require any person to explain it.

Example: If SOP says 'Select Program for garment load' then it is incomplete instruction, but if it says 'Go to recipe selection tab on HMI, select program No. 1 assigned for garment load cycle' then it is detailed enough Each step can be a maximum of three sentences. Not more than three sentences per step (not necessary, the long paragraph is boring to read, and sometimes readers can skip the critical information)

36 PHARMA machines & technology

c) Dry the parts with 0.2 µ filtered compressed air and cover the open ends with bio breathable paper. d) Keep filling needles, gassing needles, and post gassing needles connected with silicon tubing in the SS tray.

•

The detailed SOP should be clear and easy to understand.

•

Avoid direct statements of guidelines in SOP, convert the guidance words into actual practice to follow in the work area.

Example: •

Guidance for Industry September 2004 states that 'Any manual or mechanical manipulation of the sterilized drug, components, containers, or closures prior to or during aseptic assembly poses the risk of contamination and thus necessitates careful control' but it cannot use as instruction in SOP,

•

SOP should state the sterilization methods and parameters, how to bring together and assemble sterilized items, what will be the

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aseptic practices while doing so, what care to be taken (slow movement, preventing lean over, operating through access gloves, etc.)

•

Do not authorize decision-making to a doer; it may create confusion and can lead to deviation

write SOP •

Involvement of SME in SOP writing / revision / review write perfect SOP, avoids unrealistic / unnecessary steps / instructions

•

The SOPs should be written under supervision of

by HOD's of concerning departments and monitored by QA officer/ HOD QA, it can also must include the actual doer, shop floor person, the real executor, the operator, the down line supervisor who is daily involved in the activity as a team member of creating/revising SOP. It helps in avoiding SOP Vs Practice GAPs.

For example, instructions like 'select appropriate program', 'select suitable recipe' are not giving explicit instruction about which program or recipe to be selected HOW SOP BECOMES COMPLEX? •

•

•

QA usually people tend to seek CAPA for every root cause, even for rare errors. It also makes the SOP complex Every SOP writer is not an expert in MS Word.

Sometimes to write a revised SOP quickly, to avoid significant format change, the writer finds the easiest way to prevent workload formatting.

The instructions are placed, which requires the least format correction. In such a case, the written instruction does not match the sequence to the procedure, leading to repeated deviations resulting in making SOP more and more complex.

In response to regulatory observations, inadequate SOP many times give rise to audit observations. In response, rather than correcting the issue from the root level, the writer uses the easy way or copy-pastes the procedure resulting in repeated errors, and further to fix the error SOP revision is quickly written and make the SOP more complex.

WHO SHOULD WRITE SOP? •

SOP writing requires the right amount of skill and experience on the topic. Points to consider while writing an SOP.

•

SOPs should be reviewed by one or more individuals with appropriate training and experience of procedures covered in SOP. with the process.

•

Do not assign SOP writing/revision tasks to an employee who is sitting idle.

•

A person having through knowledge and experience on a given topic, an SME, should

38 PHARMA machines & technology

SOP REVISION • Revision should be considered as critical while preparing a new SOP. • Usually, SOPs are revised every two years or if there is a change in process or a revision required in response to CAPA arise from deviation, compliance with internal/external audit, and any process improvement identified by the execution team.

• There should be no restriction on SOP revision if anyone identified CAPA or gap against the practice. While revising the SOP against CAPA, also review the entire SOP for any other gaps that may be there and also correct the same during SOP revision. review the SOP for other gaps against the actual practice and do all changes simultaneously; it allows checking SOP Vs. Practice Gaps includes any update of guidelines and removes any flaws in the original version.

• SOP revision must follow the change control procedure to keep track of all modifications and identify the change in the new version. It helps to

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keep track records for the change in SOP when it comes to identifying, especially during and regulatory inspections.

• Revision history is also useful to keep track of changes made to comply with internal, external, or regulatory audits. These changes are a significant part of SOP until any change complies with the observation or regulations if identified.

These changes should identify with a special marking, either making them inclined or bold letters so that it is easy to identify.

Common errors in SOP writing and how to avoid them •

Mismatched of instructed sequence: Keep SOP instructions in a sequence as per procedure.

Example: Instruction to check utility pressures should come before starting the cycle, not after instructing to press the start button.

Common errors in SOP: writing & how to avoid them

•

•

•

•

Example: In a SOP, instruction to wear mask may be included in multiple sections of SOP such as 'general instructions at the start of SOP', and then in 'gowning procedure' section and also in 'process flow' of gowning. When same instruction is placed at multiple places, there are possibilities that while revising these instruction, it can skip at one or more places.

• Avoid suspicious instructions like: 'when felt necessary', 'if required'. The SOP must not have ifs and buts • Provide the required value, limits, and parameters. Example: SOP instructs to check utility pressure before the start of cycle, pressure requirement for each utility like WFI, Steam, compressed air, nitrogen must be mentioned in SOP

Spelling mistakes: Can change the meaning of instruction, It creates a negative image about organization, review practice, and seriousness in the documentation, especially in front of an auditor Use appropriate words for the activity: Example: Remove, empty, unload are similar words; use an appropriate word which precisely defines the activity Avoid extra statements that have no direct relation to the action: Example: An information like "Equipment will generate an alarm in abnormal condition" is a general statement, and it doesn't add value to SOP. Instead, include a separate section on alarm handling, a list of alarms, and for actions by each alarm Same instruction repeated multiple times: Avoid

40 PHARMA machines & technology

repeating the same instructions at multiple places. The terminology can differ when the same sentences repeated at numerous places.

Also, while revising SOP, if same instruction in mentioned at multiple places then there is a high probability that revision in some places can be missed. can create confusion, and may need to miss to revise all instruction while SOP revision, can lead to deviation.

• Any limitsation or parameters such as machines speed, product temperatures etc., must included in SOP with certified document.

• One can refer to another SOP for: the batch record, packing record. Provide specific references and avoid non-relevant references • All explanations, instructions should be part of SOP: don't include instructions to explain verbally, any verbal intimation.

• SOP should guide to QMS document to act upon: like, break down intimation note, in case of equipment failure HOW REGULATORS LOOK AT SOPs? Any pharma professional who had faced regulatory audits knows better to answers the questions, however, the main counter-question by auditor is 'WHERE IT IS WRITTEN IN YOUR SOP?'.

From the regulator's point of view, SOP prepared by

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an organization are essential documents that give them insight into the organization's operation. If the auditor observes, too many deviations related to SOP violation OR SOP are not correctly written. It gives a message the organization is not serious about the operations, and management is paying less attention to quality of production to achieve intended quality.

This suspicion may make the auditor dig deeper, and if they found multiple deficient SOP or considerable deviations, it may result in a harsh audit outcome, which is not a healthy sign for any organization.

HOW COMPANY MANAGEMENT LOOKS AT SOPs? From a management perspective, it is tough for higher management to digest the fact that the employees they hired to work for them have prepared deficient SOPs that are resulting in , SOPs causing a deficiency in regulatory observations.

Management puts all efforts while hiring employees; the right people with the proper education and experience are part of the organization and capable

of designing a compliant system and increasing productivity. When an audit observation emerges from deficient SOP or deficient designed systems, it creates a challenging situation for management to understand how it had happened? It may result in people losing their jobs and even their credibility in the market.

DO PEOPLE WRITE SOP OR JUST COPY-PASTE? Writing a new SOPs is customary to apply previous experience or take references from available online data. Some contents from the equipment manual can prefer for writing SOPs. However, in doing so, sometimes, non-relevant information is incidentally becoming part of SOP and, if not correctly reviewed before implementing and can lead to deviation. If instructions are not in sequence, it may lead theto operators to find their own ways to perform the activity or operate the machine; as a result, it will be challenging to get the desired output offrom equipment or production, and one may never know the root cause for the same until detailed gap assessment between SOP and practice is done.

THE PAST, THE PRESENT, THE FUTURE

for needle centering', the process to check all needles of filling stations whether it has inserted in the center with proper depth in vial or ampoule without touching edges was considered an inherent part of the process, it was not required to write in micro details steps. These detailed instructions are now mentioned in the current SOPs.

SOPs 10-15 YEARS BACK If we go back approx. 10-15 years, the writing of SOP's was compact. Employee can complete SOP in two pages. SOP was usually simple instructions, micro-level details considered routine practice, and usually was not part of SOP. Some examples: • When SOP says to 'Load vials on the vial loading platform of a washing machine', the process of opening a vial box, removing vial tray, and loading it on the platform by using a pusher was considered an inherent part of the practice and did not require to mention it separately. These detailed instructions are now mentioned in the current SOPs. • When SOP on filling machine instructs to 'check

42 PHARMA machines & technology

• When SOP says to take "printout of the process cycle", the process of placing papers in a printer, checking proper alignment of papers, and an adequate number of papers was considered an inherent part of the printing process. Accidently someone somewhere makes a mistake, and one print gets missed from a set of pages. In current SOPs, all the detailed instructions of placing

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Standard Operating Procedure

pages in printer, check an adequate number of pages and its alignment, and check the total number of pages printed is mandatory to write.

• There was no fancy of process flows, diagrams, photographs to include in all SOPs. Some important SOPs do have diagrams, photos but the usual SOPs were plain simple text. Skills of operators were more important than what was written in SOPs. • Alarms usually listed in SOP, but alarm handling procedure was not a detailed part of SOP as in current SOPs. • Screenshots of MMI were not there as there were no big MMIs and SCADAs except for a few critical types of equipment like Freeze dryers and autoclaves.

However, the details' levellevel of details was varying with the size and type of companies. The giant and reputed companies may have detailed SOPs. Present SOPs SOP today is highly detailed and advanced, with all information one can quickly know about diagrams, photos, tables, process flows, schematics, screenshots, attachments, annexures, etc. BUT SOMETIMES DIFFICULT TO FOLLOW SOP today is a great weapon to comply regulatory observations, almost all observation's one of the important CAPA is to 'REVISE THE SOP'. Revising SOP every time against an audit observation may make it complicated and difficult to follow.Putting an instruction every time against an auditan observation comes makes SOP full of instructions and makes it a wish list to be followed, this makes it and sometimes practically not possible to follow.

44 PHARMA machines & technology

The cCurrent detailed SOPs are not inadequate; they are excellent and provide a lot of insight to the readers for equipment or process operation. There is no need to be an expert in following current SOPs as it is human friendly and can take care of major human errors. The detailed instructions do not let anything to get change. However, there may be possibilities of both PRO and CON in current SOPs. While going through the SOP very carefully, one must understand the instructions to achieve as intended.

Each of us must pay the price to honour the efforts put by the writers for making the SOP as perfect as possible and making every effective execution to avoid deviations.

DOES PAST COMPLIANT SOPS IS NONC O M P L I A N T TO DAY ? D O E S C U R R E N T COMPLIANT SOPS WILL BE NON-COMPLIANT IN THE FUTURE? WHY? No technology is permanent in this world. The current technology will always replace with the latest.

Today's fully compliant SOPs can be non-compliant in the future. There are always ongoing minor/significant changes, knowingly / unknowingly done by operators/supervisors in procedure /practice. These changes are made after observing the operators while operating the equipment, followed by CAPA. A newly designed SOP for equipment or process is prepared with initial assessment and available knowledge which baseline assuming and makes it easy for execution production.

Over time, it makes the actual process slightly different from what is written in SOP, and nothing wrong with it, as change is an inherent part of any process.

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1) Earlier, Company used logbooks to keep the records to enter and exit in the production or critical area; today, it is replaced by biometrics systems.

Some companies still may continue with both logbooks as well as biometric records. CC TV is also a part of it.

2) Earlier, the operators maintain the records by manually reading the data at a specified time or intervals. These manual records are replaced by automation and digitization, In both cases, the manual process is replaced by digital; therefore, it has to periodically reviewed for procedure VS practice gaps or may lead to deviations.

CONCLUSION SOPs are essential documents of the pharmaceutical industry and required for smooth and intended operations. It has an inbuilt answer to the question raised by regulators or auditors that 'WHERE IT IS WRITTEN IN YOUR SOP?'. The SOP writing and

revision requires skills, and experienced personnel should write it. It should be detailed enough to guide properly and avoid tons of instructions and information, mMaking it overlong and monotonous to refer. SOP revision should be holistic and provide an opportunity to perform a detailed gap assessment to make it compliant with the current system and practices. One must not forget the referring SOP in depth can avoid: deviations, audit observations, lengthy investigations, and high profile CAPAs which in turn makes SOP complex. So, follow the SOPs and make others do so.

The author Mr. Dhaval Surti holds Degree in Pharmacy and diploma certification in management with more than 18 years of experience in injectable manufacturing, validation, quality assurance and new facility projects. Mr. Surti has a work experience with reputed Indian companies like Sun Pharmaceuticals, Zydus Pfizer Oncology, Emcure Pharmaceuticals and Aculife Healthcare since 2003.

He has core experience in aseptic technique, freeze drying, sterilization validation, smoke studies, SOP writing, investigations, training and media fills.

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45 PHARMA machines & technology

October - November 2020

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Review

Arab Pharma Expo

The FIRST OnLine edition of 3rd Arab Pharma Manufacturers' Expo redefined the business process for trade attendees from 24 countries Healthcare manufacturing has remained a top priority globally; even during the COVID-19 pandemic, the pharmaceutical companies have continuously invested and expanded the pharma manufacturing facilities worldwide.

The FIRST OnLine edition of the 3rd ARAB PHARMA MANUFACTURERS' EXPO 2020, focusing on Arabic countries in the Middle East & North Africa (MENA) region, drew the attention of buyers and trade professionals from 24 countries to meet virtually with the exhibiting companies for business networking and attend the technical presentations. The OnLine exhibition was COST-EFFECTIVE and integrated with all the bare essential features for the exhibiting companies to generate optimum output to display and communicate. Sixty-seven companies from 8 countries exhibited their products/services, under 470 subcategories, under 18 significant sections.

The Buyers from Algeria, Egypt, Iraq, Israel, Jordan, Lebanon, Libya, Mauritania, Morocco, Palestinian Territory, Qatar, Saudi Arabia, Sudan, Syria, Tunisia, Turkey, Yemen, UAE. had registered and attended the OnLine Exhibition. The pharma manufacturing professionals from other countries like UK, USA, India, Kenya, Ethiopia, and Nigeria had also visited and experienced the first-ever OnLine exhibition on the advanced pharma manufacturing technologies focusing on the Arab region.

MR. NOOH SAWAFTAH Regional Business Development Director Middle East & North Africa - JORDAN AUSTAR GROUP EMEA

More than 45 LiVE technical presentations addressed the latest trends and current practices of pharma manufacturing technologies by exhibitors spanning over six days. The OnLine Exhibition had remained highly resourceful for the pharma manufacturing fraternity to acquire the technology-based information.

Overall, the Exhibitors have appreciated the novel concept of the OnLine Exhibition, as it applies all the latest technical aspects to offer the optimum business networking domain bypassing all the limitations (Social Distancing, Travel, Logistics, Vulnerability to infectious diseases, and many more associated risk factors).

Outstanding benefits of the ARAB PHARMA MANUFACTURERS' EXPO 2020 (OnLine Exhibition) are to accelerates instant business connectivity, global exposure without any geographical barriers, ease of accessibilities and business networking through Mobile / Laptop / PC, longer exhibit hours, negligible investment, options of affordable packages for costeffective participation, and the most important is to bypass several other associated COSTS (Travel, Logistics, Accommodation) and TIME.

MR. M. M. PANCHAL Director - FLUIDPACK Tablet Press Manufacturing Company

MR. SANJEEV TAMHAN Director - Sales & Marketing KEVIN PROCESS TECHNOLOGIES PVT LTD

Following the guidelines on health &

The experience of

safety due to global pandemic, the 3rd ARAB

participation and reach out

Participating in the FIRST OnLine edition of the 3rd ARAB PHARMA MANUFACTURERS' EXPO 2020 was complete an outstanding as how we can utilize the technology and network with the trade professionals at targeted pharma manufacturing markets located in the other par t of the world.! Highly user-friendly navigation for both - Exhibitors and Visitors offered smooth functionalities and opportunity to represent our Products and Corporate information in precise manner. Wishing GPE EXPO PVT LTD all out success for many more similar initiatives in future, as well.!

PHARMA MANUFACTURERS' EXPO 2020 and its

across the geographical borders through

FIRST edition of the OnLine Exhibition bypasses all

participating at the FIRST OnLine edition of the

the hassles of travel, accommodation, logistics,

3rd ARAB PHARMA MANUFACTURERS' EXPO

higher cost and above all - time, to get connected with

2020 exhibition was an outstanding. It offered

the serious buyers and industry trade professionals

ease of access and excellent business

among the Middle East & North African pharma

networking opportunities against the minimal

markets. We congratulate GPE EXPO PVT LTD for

expenses.

such an excellent initiative to enable us to generate business.

46 PHARMA machines & technology

October - November 2020

Infocus

Your Partner for Liquid Dose Packaging

The BLU 200 is a blister packaging line for various liquid dose medicines in syringes, ampoules, vials, cartridges, bottles, and pens. Significant factors contributing to its high cost-effectiveness are gentle product handling, flexibility, fast cleaning, format changeovers, and straightforward operation.

“Batches are becoming smaller, particularly in the liquid dose segment. The BLU 200 is designed as an entry model. It is very cost-efficient in packaging small to medium-sized batches and quality, reliability and functionality to meet the high standards generally expected of Uhlmann”, says Werner Blersch, Product Manager at Uhlmann.

Maximum flexibility and incredibly gentle product handling The modular concept of the BLU 200 is ideal for the highly flexible packaging of ampoules, vials, cartridges, bottles, syringes, and pens. Combined in line with a cartoner, each of the machines offers scope for a variety of configurations. Options include various feeding/pack insert systems, sealed blisters or clamp packs, the extension of the fill section, or the integration of printing and inspection systems. The BLU 200 forms the heart of a flexible, customized line for the packaging of liquid dose products.

Careful handling throughout the entire packaging process protects the products from damage.

Features include low drop heights during blister removal or product position monitoring in the pressin station.

The perfect, efficient match The Cartoner C 200 covers the complete format and output range of the BLU 200. It is equipped with a dual product feeder that has two loaders. Large

47 PHARMA machines & technology

blisters are handled at an output of 120 cartons per minute. The pitch can be halved from 200 mm to 100 mm when packaging smaller products in cartons up to 85 mm in width. The C 200 then practically doubles its performance, attaining a maximum output of 200 cartons per minute.

• Optimal entry into the secondary packaging of ampoules, vials, cartridges, bottles, syringes, and pens • Highly flexible to meet a wide range of customer requirements and production conditions • Gentle product handling as well as GMPcompliant machine design promote fast, easy cleaning and enhance productivity • Efficient use of the full forming material width optimizes output Specification BLU 200 Sealing principle Scope of application Mode of operation single or Max. output Formats cartridges, Max. forming depth Max. format area [index x width] Specification C 200 Max. output cartons/min.

Max. carton size [A x B x H] Max. blister stack height Types of closure

October - November 2020

platen sealing liquid dose products single to five-lane / double-row 200 blisters/min. ampoules, vials, bottles (ø 8.25–30 mm) syringes (ø 6.5–26 mm) 33 mm 173 x 200 mm

120 or 200* 180 x 105 x 250 mm 100 mm tuck-in, hot-melt

Preview

Achema 2022

Pharma Pro&Pack Expo Expo Hyderabad edition postponed to September 2021 Due to the rampant spread of COVID-19 in the country and the consequent travel restrictions imposed by the Government of India, show organiser Messe Muenchen India together with the Indian Pharma Machinery Manufacturers Association, have announced the postponement of the Hyderabad edition of Pharma Pro&Pack Expo to 23-25 September 2021.

The trade fairs were originally scheduled from September 17–19, 2020, at Hitex Exhibition Center, Hyderabad. However, considering our stakeholders, exhibitors, and visitors' safety, the show organisers have rescheduled the trade fairs. The postponement decision is based on industry feedback received through the extensive survey conducted by the organiser.

Mr. Bhupinder Singh, the CEO, Messe Muenchen India, explained, "Owing to the restrictions enforced by the Government of India on travel and massgatherings, September 2020 is no longer a viable option to organise Pharma Pro&Pack Expo." Mr.

Scan and go deeper into 3D anatomy of the human body with the virtual reality.

48 PHARMA machines & technology

Glimpses Singh added that "Health and safety of everyone involved in the trade fairs is our prime concern. For the upcoming edition, we will strictly follow government directives and standard operating procedures to ensure a safe environment to conduct business at our trade fairs."

Mr. Mahendra Mehta, President, Indian Pharma Machinery Manufacturers Association, also commented on the postponement, "Keeping the safety of stakeholders, exhibitors and visitors at priority, postponement of the 2020 edition is a radical decision. The industry will have a great experience under better circumstances and it will make the 2021 edition a greater success" Pharma Pro&Pack Expo will bring together professionals from various verticals to foster businesses globally in the upcoming edition, scheduled in September 2021 at Hitex, Hyderabad.

About Messe Muenchen India Messe Muenchen India is a fully owned subsidiary of Messe Muenchen GmbH, founded in 2007 with a full time workforce of over seventy professionals. It organizes various B2B trade fairs across various industrial verticals to bring professionals from across sectors together for business, learning and networking opportunities.

Messe Muenchen India works closely with industry stakeholders to deliver well researched and professional trade fairs keeping in mind the priorities of the customers. With its head office in Mumbai and regional representation in New Delhi, Bengaluru and Chennai, Messe Muenchen India bring professionals from across sectors together for business, learning and networking opportunities.

October - November 2020

Preview

CPHI & P-MEC China 2020

CPhI & P-MEC China 2020 adapts to customer needs with hybrid pharma event CPhI & P-MEC China returns as a hybrid event in Shanghai (16-18 December, 2020), with a physical exhibition running alongside Virtual Expo Connect (18 November – 18 December, 2020) for international audiences unable to attend.

The physical exhibition will be held at the SNIEC (Shanghai New International Expo Center), with some 3,000 exhibitors present across three days, alongside exhibitor talks and conferences. Crucially, this year's exhibition will support international attendees with a dedicated month-long digital platform, Virtual Expo Connect.

Reacting to customer needs, CPhI & P-MEC China introduced a new hybrid model so that pharma executives (unable to visit Shanghai) can continue to meet and do business in the country – which plays such an integral role in global supply chains. In fact, China is the world's biggest ingredients producer, supplying 80% of chemicals used in European drug manufacturing and 70% of APIs to Indian manufactures - which in turn makes 40% of global generics.

“China based companies are absolutely vital in the pharma supply chain. It is therefore essential international pharma is able to meet with partners here to support the delivery of medicines globally.

For international attendees to connect with Chinabased suppliers, we created a special digital platform. Virtual Expo Connect provides access to thousands of potential suppliers over a one-month long period of engagement, allowing pharma to source connections to support manufacturing needs.

To sustain global growth, it is crucial that overseas professionals can meet with companies from the world's largest pharma ingredients market,” commented Laura Murina – Brand Manager CPhI & P-MEC China, Informa Markets The onsite and digital exhibitors will span the full supply chain in China – from ingredients and machinery to contract services, biologics, finished

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Virtual Expo Connect to empower access for international pharma to the world's largest pharma ingredients market dosage and packaging.

Virtual Expo Connect will have a number of digital features at the disposal of online attendees. For example, the Digital Showroom will showcase products and services from the event's exhibitors, with attendees able to search for suppliers and request video meetings. Business development will be further facilitated by the online matchmaking service, which uses precise targeting to source the most appropriate partners. The virtual expo also provides hosted buyer video meetings, a customised one-to-one digital meeting service tailored to individual purchasing requirements.

Additionally, to stay informed on the latest challenges and opportunities, the exhibitor talks will feature in-depth interviews with senior management from across leading pharmaceutical companies in China. Further industry expert insights will also be provided by the conference webcasts, which are available to livestream and on-demand.

Finally, for a fully immersive experience of CPhI & PMEC China, virtual attendees will have the chance to tour the show floor via both a 360o virtual reality view of the show floor and livestreamed virtual guided tours.

Murina added “Following the success of the recent CPhI: Festival of Pharma, we realised the importance for international audiences of combining the benefits of Virtual Expo Connect. Yet with our 360o virtual reality and guided tours we have taken this a step further and we now empower the global community with a truly immersive digital event experience. The online and on-demand conference agenda will deliver vital information on market dynamics, opportunities and trends. All from the comfort of executives own computers and over an extended month-long period.”

International attendees can register for https://www.cphi.com

October - November 2020

Preview

Achema 2022

ACHEMA postponed to 2022 ACHEMA 2021 has postponed to April 4-8, 2022. This decision was taken after intensive discussions with the community and in the ACHEMA Committee in view of the continuing uncertainty caused by the Corona pandemic. From June 15-16, 2021, ACHEMA Pulse will offer the worldwide ACHEMA community the opportunity to learn about the latest trends and make new contacts with highlight sessions, top-class discussions and lectures as well as interactive formats.

Seven months before the start the organizers have decided to postpone ACHEMA to April 4-8, 2022 after intensive consultation with exhibitors and partners.

With this early decision DECHEMA wants to give exhibitors planning security in the light of the long-term preparation and investment required by a show of this size. The ACHEMA Committee, representing the exhibitors, had previously also unanimously voted for a postponement to 2022, expressing at the same time their strong commitment to ACHEMA. "Our claim is to be the global meeting place for the process industry and to make it possible to experience it with all senses", explains Dr.-Ing. Thomas Scheuring, CEO of DECHEMA Ausstellungs-GmbH. "As things stand at present, we will not be able to live up to this claim in June 2021, because we have to assume that travel will not yet be unrestricted at that time". The organizers see the postponement by about nine months as an opportunity to create a diverse, lively and multisensorial ACHEMA. "We want to meet the expectations of exhibitors and visitors for an ACHEMA", explains Dr. Bjรถrn Mathes, Member of the Executive Board of DECHEMA Ausstellungs-GmbH. This requires a comprehensive exhibition program and the opportunity for personal contact.

However, exhibitors and visitors do not have to do without the global exchange on the latest trends in the chemical, pharmaceutical and food industries in June 2021: From June 15-16, 2021 ACHEMA Pulse will provide inspiration for new solutions that the industries urgently need right now. Presentations by top-class and visionary speakers will shed light on the latest topics in the process industry, linked to interactive discussion formats and lectures that address key global issues of relevance to the ACHEMA community. In addition to the focus topics Digital Lab, Modular and Connected Production and Product and Process Security, these include the launch of the Digital Hub with its many aspects. Sustainability is also on the agenda of

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ACHEMA Pulse. In virtual PRAXISforums participants can find out about concrete technology developments.

In addition, the winning teams of the first ACHEMA Innovation Challenge will present their solutions to the global community. In this interactive competition teams of students, companies or start-ups develop solutions to questions that currently concern many companies. The Challenge starts in January 2021, pre-registration will open shortly.

Via the ACHEMA Pulse Platform, exhibitors and participants can also expand their business networks, make contacts and start conversations. The platform deliberately dispenses with a graphically animated exhibition. Instead, it offers fully integrated digital company and product/service profiles in which exhibitors can individually present the diversity of their offerings. Participants can contact each other at any time via chat, audio or video call. In addition, sophisticated matchmaking options allow contact to be established on the basis of offers or requests or even speed dating based on common areas of interest. The intelligent individual calendar ensures that time at ACHEMA Pulse can be used optimally.

This makes ACHEMA Pulse an interactive and flexible business platform for the process industry, which further brings the ACHEMA motto "Inspiring Sustainable Connections" to life. "When developing the platform it was important to us that the ACHEMA community has numerous opportunities to take advantage of this business platform and initiate discussions or topics themselves. More digital interaction is part of the strategic concept of future ACHEMAs, and we are glad that we started developing a corresponding offering at a very early stage," says Bjรถrn Mathes. "This is not a substitute for a physical exhibition, but rather a valuable addition, which however already now offers us the opportunity to set impulses and initiate contacts that can be developed further until April 2022".

October - November 2020

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