GMP Documentation and Record Retention

A healthy documentation system is reflective of the quality assurance mechanisms employed in a pharmaceutical manufacturing company. This course introduces you to standards of documentation and records keeping in concert with GMP. A robust documentation and records system provides a framework for looking at the manufacturing process over time at a glance This is very instrumental in making future changes as needed. You will also be introduced to the WHO guidance on good data and record management.

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: Why Do We Need Documentation and Record Retention?

Lesson 2: What is The Scope of GMP Documentation and Record Retention?

Lesson 3: Role of Quality Assurance System in Control and Retention of GMP Documents

Lesson 4: Types of GMP Documents

• Instruction Type Documents
• Record Type Documents

Lesson 5: The Harmonized Requirements of GMP Documentation and Record Retention

• The WHO Guidance on Good Data and Record Management Practices
• Annex 5: Good Data and Record Management Practices
• The USFDA Guidance for Industry: Electronic Records: Electronic                                Signatures: Scope and Application.
• The EU Guidelines on Good Manufacturing Practice for Medicinal Products                for Human and Veterinary Use: Documentation

Glossary

Conclusion

Quiz