Records, Archiving, and Retention

Hardly can one say they have been educated on pharmaceutical manufacturing without having come across the saying “if it wasn’t documented, it never happened”. This emphasizes the importance of documentation in the manufacturing process. This is what this course is about.

Participants will learn about how documented information is managed based on relevance and age (archiving and retention). You will also learn about how such information can be leveraged for future changes to the production process.

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: What Are Good Data and Record Management Practices?

• Need for Good Data and Record Management Practices
• What Comes Under Good Data and Record Management Practices
• Who Is Responsible for Good Data and Record Management Practices?

Lesson 2: Implementation of Good Data and Record Management Practices in GXP

Lesson 3: Life Cycle of a Record

• Data Collection and Recording
• Data Processing
• Data Review and Reporting
• Data Retention and Retrieval

Lesson 4: Organization of Records System in A GXP Set-up

• Hierarchical Document System
• Level 1- Quality Manual
• Level 2- Company Policies
• Level 3- SOPs
• Level 4- Batch Records, Tests Methods, Specifications, Validation Documents

Lesson 5: Master Document of a GXP Set-up: Site Master File

• Components of a Site Master File

Lesson 6: List of Common Documents Maintained in GXP Set-up

• Information Needed in Documents as Per GDRP
• Document 1: Specifications
• Document 2: Manufacturing Formula and Processing Instructions
• Document 3: Packaging Instructions
• Document 4: Batch Processing Records
• Document 5: Batch Packaging Records
• Document 6: Receipt

Lesson 7: Records, Archiving, and Retention Using GDRP Principles in a GXP Set-up

• Key Points for Records
• Electronic Record Validation
• Record Maintenance, Retention, & Archiving

Glossary

Conclusion

Quiz