GXP2960 Introduction to Current Good Practices (CGXP)

The quality, efficacy, and safety of medicinal products are assured by employing guidelines appropriate for each stage of the manufacturing and distribution process. Current Good Practices (cGxP) is a set of such guidelines which have been put together by regulatory agencies such as WHO, EU, FDA, etc. This course helps participants understand the concept of cGxP, highlighting the advantage that it presents. You will also learn about non-compliance which is a major threat to the production of high-quality products. Finally, you get to see how regulatory bodies help to enforce these guidelines with inspections, audits, sanctions, and denial of marketing authorization.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: An Understanding to cGxP

• What is cGxP?
• Impact of cGxP

Lesson 2: Regulatory bodies for Pharmaceutical Industry

• Key GxPs in Pharmaceutical Industry

Lesson 3: Non-Compliance: A Major Obstacle

• Challenges in Compliance Management
• A RoadMap For Building an Effective and Efficient Compliance Management System
• Internal Initiatives

Lesson 4: Meeting and Maintaining the Standards Required for Good Practices in Pharma

Lesson 5: The Impact of Covid-19 on Biologics Regulations

• Role of MHRA
• Good Clinical Practice
• Good Laboratory Practice Compliance

Lesson 6: Training in Good Data and Record Management

• Good Documentation Practices

Lesson 7: Designing and Validating systems to Assure Data Quality and Reliability

• Validation to Assure Good Documentation Practices for Electronic Data
• User Involvement
• Configuration and Design Controls

Lesson 8: Data Life Cycle

• SOPs and Training
• Managing Data and Records Throughout the Data Life Cycle
• Data Collection and Recording
• Example Consideration
• Data Processing
• Example Considerations
• Data Review and Reporting
• Data Retention and Retrieval
• Addressing Data Reliability Issues

Lesson 9: Implementation of cGxP

• GxP Readiness Checklist
• Prepare for Your Validation Process

Conclusion

Glossary

Quiz