Quality Management System for Pharmaceutical Industry

Quality

Management System for Pharmaceutical Industry

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About Pharmaceutical Industry

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Pharmaceutical Manufacturing Operations

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Challenges in Pharma Sector

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Reasons of quality failure in pharma industry

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What is Quality Assurance & Why it is Important?

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Importance of a Quality Management System

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What is a Pharma QMS?

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Core Principles of a QMS

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Features & Benefits of a Pharma QMS

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How Does It Help?

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Why BM Quality Master is the preferred choice?

About Pharmaceutical Industry Industry that works in the matter of researching, innovating, developing, and manufacturing of drugs and medications to speed up the treatment process.

Typical Pharmaceutical Manufacturing Operations

Typical Pharmaceutical Manufacturing Operationst

SourceReport of Small Business & Industry Assistance (SBIA)

Challenges in Pharma Sector Ø Supply chain disruptions Ø Inefficient data collection & storage Ø Lack of agility & transparency Ø Compliance issues with the changing industry standards Ø Excessive production turnaround time Ø High costs of Research & Development and Innovation Ø Maintaining various dosage forms Ø Human error & customer Satisfaction

Reasons of Quality Failure in Pharma Manufacturing In pharmaceuticals, process deviation or quality failure could endanger the health of the patient. This can also result in regulatory violation that ends up with fines and an expensive market setback. Here are most common causes of pharmaceutical quality failure are: Ø Contamination (Especially in batch production) Ø Equipment failure due to delayed maintenance Ø Inappropriate flow of data Ø Absence of written procedure Ø Imprecise formulation

What is Quality Assurance & Why It Is Important?

Quality assurance is on of the important aspects of the drug manufacturing industry. It prevents organizations from getting caught in the legal penalties of regulatory bodies.

The prominent objectives of quality assurance are: Ø Ensuring public’s safety Ø Preventing brand defamation Ø Increasing product efficiency continually Ø Helping to meet compliance standards Ø Ensuring good clinical practice for trials

Importance of a QMS for Pharma A quality management system helps organizations to run as effectively as they can to produce exceptional results.

Automation of processes helps pharma businesses to increase productivity & reach their goals in-time. Here are the reasons why it is beneficial to install a QMS: It Ø Lessens the risk of errors Ø Cuts costs by minimizing the waste Ø Keeps companies compliant Ø Enhances customer satisfaction with high-quality products Ø Helps maintain brand image by eliminating recalls

What is a Pharma QMS? A Quality Management Software is a managerial approach towards drug manufacturing that helps manufacturers to instill a quality culture– ensuring all products are meeting the required quality standards.

It checks all the critical stages of drug manufacturing, including: Formulation Method development Facilities Utility system Equipment

Core ISO Principles of a QMS A Quality Manufacturing System is a comprehensive software that works adopting all of the below mentioned quality-control practices. Ø Increasing Customer Focus Ø Efficient Resource Management Ø Installing a Standard Processing Approach Ø Maintaining Continuous Improvement Ø Establishing Effective Communication Ø Risk Assessment Ø Evidence-Based Decision Making

Features of a Pharma QMS An efficient & competent pharmaceutical quality management system instills a customerfocused culture, boosts operational efficiency, and incorporates other QMS principles for highly regulated industries. Here are some prominent labor-saving features of a pharmaceutical QMS: Non-Conformance - Identify, document, investigate, and discard the non-conformities.

CAPA - With this module, the users can address underlying quality issues and execute containment actions to prevent recurring.

Complaint Management - Very important in today’s customer-oriented environment, this module of QMS can register, track, resolve, and close customers’ quality complaints.

Features of a Pharma QMS Training Management - This capability of a QMS upskills the company’s staff by automating training procedures and fosters continuous improvement within the organization.

Change Management - From initiating change requests to evaluating, implementing, verifying, and closing, this module helps manage every step of the change control process.

Document Management - To manage the whole lifecycle of every document from creating, storing, tracking, retrieving, etc. this module is essential.

Features of a Pharma QMS Compliance Management - To automate alerts for loopholes & potential issues to manage compliance, this module helps companies to stay compliant with the stringent SOX, FDA, and ISO guidelines.

Risk Management - Crucial to all business, this module identifies, categorizes, and assesses risks proficiently, and helps eliminate it permanently.

Audit Management - To provide insightful business data to automate & streamline the process of audits.

Benefits That a “QMS for Pharmaceutical” Provides Ø Promotes effective and faster execution of processes– adhering to the CGMP norms Ø Increases customer satisfaction with precise manufacturing Ø Elevates brand value by adhering to safety standards Ø End-to-end traceability to reduce waste and speed recalls Ø Increases efficiency by improving supply chain performance Ø Enhances safety by reducing risks

Why BM Quality Master is the preferred choice?

BM QualityMaster is a powerful and easy-to-use Total Quality Management Software that allows you to improve quality, achieve compliance, lower risk, and reduce complaints by streamlining your quality management. Ø Quick implementation & easy to use Ø Scalable to your needs as the business grows Ø Seamless integration to enhance functionality Ø Cloud-based approach that offers complete flexibility & safety Ø Offers low-cost implementation Ø Available on cloud and on-premise Ø Accessible for anywhere, at anytime and through any-device Ø Personalized Dashboards for direct access to workflows

Conclusion Ø The pharmaceutical industry is highly regulated by the regulatory bodies such as FDA, ISO, etc. Hence, every pharma company should have efficient resources to ensure safe and quality products. Ø Incorporation of a competent QMS for pharma industry like BM Quality Master provides a helping hand to pharma manufacturers to streamline their core operations and lead with a problem-solving approach. Ø Get in touch with our team of experts today.

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BM QualityMaster is a product of BatchMaster Software Pvt. Ltd. From last 20 plus years, we are a leading business software development company with noteworthy ERP, QMS, HRMS and other technological products. we have offices around the globe to serve customers from all geographies and industries.

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