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Overview of GMP and Quality Concepts in Pharmaceuticals and Biotechnology

This module covers the basics of Good Manufacturing Practice (GMP) including the importance of following personal hygiene and data integrity in the drug companies.

  • Historical global inspection data on errors and non-compliance

  • Sources of typical GMP error

  • Importance of root cause determination and introduction to concept of corrective and preventive action (CAPA)

  • Personal hygiene including hand washing procedures and its importance in assuring product quality and patient safety

  • A short review on the 10 golden rules of GMP

  • Quality standards required in premises, equipment, and instrumentation

  • Data integrity and its importance in all aspects of drug manufacturing and quality testing

  • Animation: ALCOA and ALCOA +

  • Typical Do’s and Don’ts when recording data

  • Gamification to ensure users are engaged for this long and thorough module

Why it matters

Many GMP violations can be traced to human errors. Improving systems and processes can lead to a significant reduction in these errors\, and aid in GMP compliance. This includes identifying error-prone areas\, simplifying instructions\, better data management\, and capability-based assignments. GMP training is important to introduce workers to the possible sources of errors and to practices that can minimize the same.

Who is it for

This module is required training for all new employees and is a good refresher for all existing employees involved in GMP functions.

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