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