Certified Pharmaceutical GMP Professional Practice

According to GMP, what should documentation achieve?

1. Capture only critical manufacturing aspects

2. Define processes and capture all aspects of manufacturing

3. Maintain records for regulatory compliance only

4. Document only product failures and complaints

The correct answer is: Define processes and capture all aspects of manufacturing

Documentation in Good Manufacturing Practice (GMP) serves a comprehensive purpose that is crucial for ensuring product quality, safety, and compliance with regulations. The correct answer emphasizes the importance of defining processes and capturing all aspects of manufacturing. This holistic approach is essential because thorough documentation allows for the standardization of procedures, which is vital for maintaining consistency and quality in production. By capturing all aspects of manufacturing, documentation provides a clear traceable record of what was done, why it was done, and how it was achieved. This not only aids in internal audits and quality control but also enables organizations to provide clear evidence of compliance during regulatory inspections. Additionally, it facilitates the identification of areas for improvement by documenting both normal operations and any deviations or non-conformances. The other options are limited in scope. Focusing only on critical aspects overlooks many important details that contribute to overall product quality. Maintaining records solely for regulatory compliance ignores the broader benefits of documentation in operational efficiency and continuous improvement. Documenting only failures and complaints fails to provide a complete picture of manufacturing processes, which is necessary for effectively managing quality systems. Thus, comprehensive documentation is a cornerstone of GMP.