Good Documentation Practice (GDocP)

Good Documentation Practices (GDocP) are a fundamental part of GMP compliance in pharmaceutical and medical-device organizations. They ensure that every process, from manufacturing to testing, is accurately recorded, traceable, and verifiable. Proper documentation not only supports product quality but also demonstrates the robustness of a company’s quality assurance system.

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.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who should enroll?

• Quality assurance and control professionals
• Regulatory affairs specialists
• Manufacturing and lab personnel handling documentation
• Internal auditors and compliance teams

🎯 What you’ll learn?

• Principles of Good Documentation Practices in GMP
• How to complete, review, and maintain different GMP documents
• Identify and correct common documentation errors
• Ensure compliance through proper document control and retention

Curriculum:

 
Introduction
Chapter 1 : What are Good Documentation Practices?
Chapter 2 : How and when to apply Good Documentation PracticesChapter 3: Document types