GMP ICH Q7 Documentation Kit

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com Chapter-1.0 CONTENTS OF GMP ICH Q7 DOCUMENT KIT (Good Manufacturing Practices for Pharmaceutical companies based on API) (More than 185 document files) The Total editable document kit has 7 main directories as below.

GMP- ICH Q7 Editable Document kit for API manufacturer Sr. No.

List of Directory

Document of Details

1.

GMP Manual

20 chapter and 05 annexure in MS Word

2.

Procedures

08 procedures in MS Word

3.

Process approach Standard operating procedures

4.

5.

6.

10 process approach in MS Word 75 standard operating procedure in MS Word

Personnel and administration (PA)

17 Standard operating procedure in MS Word

Quality Assurance (QA)

53 Standard operating procedure in MS Word

System (SYS)

05 Standard operating procedure in MS Word

Exhibits

06 Exhibits in MS Word

Formats

64 formats in MS Word

Engineering (ENG)

03 formats in MS Word

Purchase (PUR)

05 formats in MS Word

Despatch (DES)

05 formats in MS Word

Housekeeping (HKC)

04 formats in MS Word

Marketing (MKT)

03 formats in MS Word

Production (PRD)

05 formats in MS Word

Quality assurance (QA)

11 formats in MS Word

Quality control (QCD)

06 formats in MS Word

Stores (STR)

05 formats in MS Word

System (SYS)

11 formats in MS Word

Training (TRG)

06 formats in MS Word

7.

Audit checklist

8.

GMP Q7 compliance matrix (Requirements wise reference documented information)

More than 800 questions 01 file in MS excel

Total 185 files quick download in editable form by e delivery To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 1 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com B. Documentation:Our document kit is having sample documents required for GMP Q7 certification as listed below. You need to study it do necessary changes as per your company need and within 4 days your entire editable documents with all necessary details are ready as well as your team will gotmany ideas for system establishment to reduce the cost and effort with all necessary controls and your total documentsare ready. We had given all type of templates and organization use it as per their need and many organizations are certified globally in 1st trial with the help of our documents from any kind of stringent lead appraisal audit.

Under this directory further files are made in word document as per the details listed below. All the documents are related to GMP Q7 for and user can edit it in line with their own processes.

1. GMP Manual: It covers sample copy of manual for GMPQ7 ICH Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. It covers 20 chapter and 05 annexure as well as list of procedures as well as overview of covers tier1 of GMP Q7 documents.

GMP Q7 Manual Index Chapter No. 1.0 2.0 2.1 2.2 2.3 2.4 2.5 3.0 3.1 3.2 3.3 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7

Subject Company Profile Introduction Table of Contents Quality management Principles Responsibilities of the Quality Unit Responsibility for production activities Internal audits Product quality review Personnel Personnel Qualifications Personnel Hygiene Consultants Building and Facilities Design and Construction Utilities Water Containment Lighting Sewage and Refuse Sanitation and Maintenance

Page No.

1–7

1–3

1–1

1–2

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 2 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com 5.0 5.1 5.2 5.3 5.4 6.0 6.1 6.2 6.3 6.4 6.5 6.6 6.7 7.0 7.1 7.2 7.3 7.4 7.5 8.0 8.1 8.2 8.3 8.4 8.5 9.0 9.1 9.2 9.3 9.4 10.0 10.1 10.2 11.0 11.1 11.2 11.3 11.4 11.5 11.6

Process Equipment Design and Construction Equipment Maintenance and Cleaning Calibration Computerized Systems Documentation & Records Documentation System and Specifications Equipment Cleaning and Use Record Records of Raw Materials, Intermediates, API Labeling and Packaging Materials Master Production Instructions (Master Production and Control Records) Batch Production Records (Batch Production and Control Records) Laboratory Control Records Batch Production Record Review Materials Management General Controls Receipt and Quarantine Sampling and Testing of Incoming Production Materials Storage Re-evaluation Production & in-process control Production Operations Time Limits In-process Sampling and Controls Blending Batches of Intermediates or APIs Contamination Control Packaging and identification labeling of APIs and intermediates General Packaging Materials Label Issuance and Control Packaging and Labeling Operations Storage and Distribution Warehousing Procedures Distribution Procedures Laboratory Controls General Controls Testing of Intermediates and APIs Validation of Analytical Procedures Certificates of Analysis Stability Monitoring of APIs Expiry and Retest Dating

1–2

1–4

1–2

1–2

1–2

1–1

1–2

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 3 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com 11.7 12.0 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 13.0 14.0 14.1 14.2 14.3 14.4 14.5 15.0 16.0 17.0 17.1 17.2 17.3 17.4 17.5 17.6 17.7 17.8 18.0 18.1 18.2 18.3 18.4 18.5 19.0 19.1 19.2 19.3 19.4 19.5

Reserve/Retention Samples Validation Validation Policy Validation Documentation Qualification Approaches to Process Validation Process Validation Program Periodic Review of Validated Systems Cleaning Validation Validation of Analytical Methods Change control Rejection and Re-use of materials Rejection Reprocessing Reworking Recovery of Materials and Solvents Returns Complaints and recalls Contract manufacturers (Including Laboratories) Agents, Brokers, Traders, Distributors, Repackers and Relabellers Applicability Traceability of Distributed APIs and Intermediates Quality Management Repackaging, Relabeling and Holding of APIs and Intermediates Stability Transfer of Information Handling of Complaints and Recalls Handling of Returns Specific guidance for APIs manufactured by cell culture / fermentation General Cell Bank Maintenance and Record Keeping Cell Culture/Fermentation Harvesting, Isolation and Purification Viral Removal/Inactivation steps APIs for use in clinical trials General Quality Equipment and Facilities Control of Raw Materials Production

1–2

1–1

1–2

1–1 1–1

1–2

1–3

1–2

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 4 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com 19.6 19.7 19.8 19.9 20.0

Validation Changes Laboratory Controls Documentation Glossary

1–4 Annexure

ANX-I ANX-II ANX-III ANX-IV ANX–V

1–1 1–1 1–2 1–1 1–1

List of GMP Procedures Glossary of Terms Process Flow Chart Organization structure Quality Policy

2. Procedures (08 Procedures): It covers sample copy of mandatory procedures covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

List of procedure 1.

2.

3.

4.

5.

6.

7.

8.

Procedure for management review Procedure for document and data control Procedure for Control of Records Procedure for internal audit Procedure for Training Procedure for corrective and preventive action Procedure for Control of Monitoring and Measuring equipments Procedure for Control of Non–Conforming Products

3. Process approach (10 process approach): It covers sample copy of process approach covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

List of process approach 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Process Flow Chart of Customer Service Process Flow Chart of Dispatch Process Flow Chart of Engineering Process Flow Chart of Marketing Process Flow Chart of Production Process Flow Chart of Purchase Process Flow Chart of Quality Control Process Flow Chart of System Coordinator processes Process Flow Chart of Stores Process Flow for Training Activity

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 5 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com 4. Standard operating procedures (74 SOPs): It covers sample copy of standard operating procedures covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

List of standard operating procedures (SOPs) 1.

SOP for personnel and administration

2.

SOP for medical checkup of employees

3.

SOP for personnel hygiene

4.

SOP for cleaning & sanitization of factory premises

5.

SOP for garbage disposal

6.

SOP for maintenance of building

7.

SOP for scrap disposal

8.

SOP for security system

9.

SOP for safety training

10. SOP for first aid training

11. SOP for induction training

12. SOP for pest control

13. SOP for entry and exit for visitors

14. SOP for cleaning procedure for uniforms

15. SOP for dress code

16. SOP for record of specimen signature

17. SOP for job responsibility

18. SOP for SOP

19.

SOP for Control of Version, Archival and Retrieval of Data

20.

SOP for Receipt and Handling of Market Complaints

21. SOP for Product recall

22. SOP for Handling of market returns

23. SOP for Change control system

24. SOP for Deviation and Investigation

25. SOP for Quality audit

26. SOP for Internal audit (self inspection)

27. SOP for Non-conformance Procedure

28. SOP for Non-conformance of Materials

29. SOP for Vendor quality audit

30.

31.

SOP for Calibration and Preventive Maintenance of Equipment/Instrument

SOP for Purchasing quality materials from approved vendors

32. SOP for Out of Calibration (OOC)

33. SOP for Out of specification (OOS)

34. SOP for Generation and Movement of Artwork

35. SOP for Rework procedure

36.

SOP for Numbering and Codification System For Master Documents

37.

SOP for Sampling procedure for finished product analysis

38. SOP for Entry Procedure for Sampling Area

39.

SOP for In-process Manufacturing

40. SOP for Cleaning of sampling equipments

Inspection

During

41. SOP for Disposition of rejected materials 43.

SOP for Handling and storage of raw material control samples

42. SOP for Destruction procedure for samples 44. SOP for Shelf life of finished product formulations

45. SOP for Annual review of finish products

46. SOP for Printed product label control

47. SOP for Printed product carton control

48. SOP for Line clearance

49.

SOP for Disposition of components and products

50. SOP for Batch reconciliation

51.

SOP for Handling and storage of controlled samples

52. SOP for Retain samples and its disposal

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 6 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com 53.

SOP for Preparation of Master Batch Manufacturing Record

54. SOP for Stability study

55. SOP for Corrective and Preventive Action

56. SOP for Mock recall

57. SOP for Training system

58. SOP for Batch release of Finished Products

59.

SOP for Equipment Status Labeling and Equipment Logbook Entry

60. SOP for Failure investigation

61. SOP for Introduction to validation

62. SOP for Fundamentals of validation sop

63. SOP for Guidelines for DQ, IQ, OQ & PQ

SOP for Design qualification guideline for 64. minimizing the risk of product crosscontamination by air handling unit

65. SOP for Validation glossary

66. SOP for Revalidation

67.

SOP for Guidelines for area validation: clean area

68. SOP for Validation of HVAC system

69. SOP for Analyst validation

70. SOP for Prevention of Cross Contamination

71. SOP for Housekeeping & Cleaning

72.

73.

SOP for Cleaning of Doors, Windows, Walls and Tube light and Fan

SOP for Building Maintenance and General Facilities

74. SOP for Personal Hygiene

5. Exhibits (06 exhibits): It covers sample copy of exhibits covering all the details of Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

List of exhibits 1.

2.

3.

4.

5.

6.

Skill requirements Multi Skill requirements Control of non–conforming products Document codification system Quality Plan Raw material specification

6. Blank Formats (64 Formats): It covers sample copy of blank forms required to maintain records as well as establish control and make system. The samples given are as a guide and not compulsory to follow to change the same to suit own requirements.

List of Formats 1.

3.

5.

7.

Master List & Distribution List of Documents Corrective Action Report Quality Objectives Monitoring Sheet SYS Internal Quality Audit Non–Conformity Report 9.

Quality Objective Plan 11. List of License / certificates 13. Employee Wise Training & Competence

2.

4.

6.

8.

Change Note Master List of Records Audit Plan / Schedule

10.

12.

14.

Calibration Status of Instrument / Equipment Training Calendar Induction Training Report

GMP Clause wise Audit Review Report

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 7 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com Record Sheet 15. Job Description & Specification 17. Skill Matrix 19.

Indent And Incoming Inspection Record

16.

18.

20.

21.

23.

25.

27.

29.

31.

33.

35.

37.

39.

External Provider Registration Form Order Form / Order Confirmation Customer Feed Back Form Preventive Maintenance Schedule Gate pass Preservation Assessment Report Unloading Vehicle Checking Report Disposal of Non-Conforming Products Tray Dryer Log Sheet Sample Test Request Slip For Incoming materials 41. Normality Record Sheet 43. Stability Study Report 45.

Packing Report / Slip

22.

24.

26.

28.

30.

32.

34.

36.

38.

40.

47. Screen Checking Report 49. Loading Vehicle Checking Report 51. Visitor’s Entry Report 53.

Equipment Cleaning Report

48.

50.

52.

54.

55.

57.

59.

61.

63.

56.

58.

60.

62.

64.

Line Clearance Label Out of Calibration Label Recall Format Mock Recall Form Out of Specification Log

42.

44.

46.

Training Report Purchase Order Approved external provider list & Annual purchase order Annual Purchase Order Customer Complaint Report Breakdown History Card Preventive Maintenance Check Points Material Issue Slip Goods Receipt Note Production Plan Blending Data Sheet Spin Flash Dryer Log Sheet Sample Test Request Slip For In process / Finish product pH Meter Calibration Report Equipment Cleaning Validation Report Bag / Other Packing Material Inspection Report Label issue register Cleaning and Sanitation Report Sanitation Audit Report Laboratory Investigation Report For Out Of Specification Record For Rework Vendor Audit Report Stability Protocol and Report Destruction Approval Form Deviation Report Form

7. Audit Checklist (more than 800 questions) It covers sample audit questions based on all the GMP Q7 good manufacturing practice guidancerequirements based on GMP ICH Q7 standard. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the Q7 good manufacturing practice guidance requirements are fulfilled.

8. GMP ICH Q7 compliance matrix The Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients based on ICH guidance requirement wise list of documented information reference of this kit is given in compliance matrix for ready reference to user to understand how this system is made.

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 8 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com Chapter-2.0 ABOUT COMPANY Global manager group is a progressive company promoted by a group of qualified engineers and management graduates having rich experience of over 25 years in ISO consultancy and management areas. The company serves the global customers through on-site and off-site modes of service delivery systems. We offer a full range of consulting services geared towards helping all types of organizations to achieve competitiveness, certification and compliance to international standards and regulations. So far, we have more than 2700 clients in more than 36 countries.

Our readymade training kit and editable documentation kit help the clients in making their documents with ease and complying with the related ISO standard faster.

1. Our promoters and engineers have rich experience of providing management training and ISO series consultancy for more than 2700 companies globally. We have clients in more than 36 countries.

2. We are a highly qualified team of 80 members (M.B.A., Degree Engineers). Our Director has rich professional experience in this field (since 1991).

3. We have 100% success rate in ISO series certification for our clients from reputed certifying bodies. We possess a branded image and are a leading name in the global market.

4. We suggest continual improvement and cost reduction measures as well as provide highly informative training presentations and other products that give you payback within 2 months against our cost.

5. So far, we have trained more than 50000 employees in ISO series certification.

6. We have spent more than 60000 man-days (170 man-years) in the preparation of ISO documents and training slides.

Global Manager Group is committed for: 1. Personal involvement and commitment from the day one 2. Optimum charges 3. Professional approach and globally helped many companies for this standard.

4. Hard work and updating the knowledge of team members 5. Strengthening clients by system establishment and providing best training materials in any areas of management to make their house in proper manner 6. Establishing strong internal control with the help of system and use of the latest management techniques.

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 9 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com Chapter-3.0 USER FUNCTION 3.1 Hardware and Software Requirements A. Hardware 

Our documentation kit can better perform with P4 and higher computers with a minimum of 10 GB hard disk space.



For better visual impact, you may keep the setting at high color.

B. Software



Documents are written in MS-Office 2007 and Windows XP programs. You are, therefore, required to have MS-Office 2007 or higher versions with Windows XP. 3.2 Features of Documentation kit



The kit contains all necessary documents as listed, and complies with the requirements of system standards.



The documents are written in easy to understand English language.



This kit will save much time in typing and preparing your documents at your own.



The kit is user-friendly to adopt and easy to learn.



The contents of this kit are developed under the guidance of experienced experts.



The kit provides a model of the management system that is simple and free from excessive paperwork.

To get more information about GMP ICH Q7 Documentation kit Click Here www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322

Page 10 of 11

D139: DEMO OF GMP ICH Q7 DOCUMENT KIT Price 599 USD (Applicable for Pharmaceuticals manufacturer based on Active Pharmaceutical ingredients (API)

Complete editable Good Manufacturing Practices (GMP) Q7 document kit (Manual, procedures, process approach, exhibits, SOPs, formats, audit checklist etc.)

Buy: www.globalmanagergroup.com Chapter-4.0 BENEFITS OF USING OUR DOCUMENTATION KIT 1. By using these documents, you can save a lot of your precious time while preparing the GMP ICH Q7 documents.

2. The kit takes care of all the sections and sub-sections of GMP ICH Q7 standards and helps you to establish better system.

3. This documentation kit enables you to change the contents and print as many copies as you need. The users can modify the documents as per their industry requirements and create their own GMP ICH Q7 documents for their organization.

4. It will save much cost in document preparation.

5. You will get a better control in your system due to our proven formats.

6. You will also get a better control in your system as our proven documents and templates are developed under the guidance of experts and globally proven consultants. The team has a rich experience of more than 25 years in the ISO consultancy.

7. Our products are highly sold across the globe and are used by many multinational companies.

They have got total satisfaction as well as experienced value for money.

8. In the preparation of documentation kit, our team has verified and evaluated the entire content at various levels. More than 1000 hours have been spent in the preparation of this documentation kit.

9. The entire kit is prepared by a globally proven team of leading ISO consultants.

Chapter-5.0 METHOD OF ONLINE DELIVERY On completion of the secured purchase, we provide a username and password to download the product from our FTP server. We provide instant online delivery of the kit to the users by sending an e-mail of username and password.

For purchase, Click Here

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Visit our website for more details on the documentation kit: https://www.globalmanagergroup.com/Eshop

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Page 11 of 11