Foundations of Good Manufacturing Practices

Good Manufacturing Practices (GMP) are critical to ensuring a medical product is quality assured and fit for its intended use. Achieving both protects the public from substandard products and helps to maintain and/or improve the health and well-being of patients.

Basic GMP principles are specified by the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Many countries have their own GMP guidelines, which are often based on the WHO standard. Manufacturers must comply with the regulatory requirements of the countries where they produce and market their products.

This free online course provides an overview of essential GMP principles and requirements. It covers key principles of the WHO and PIC/S standards and will equip participants with a broad, foundational understanding of GMP.

Developed by the Promoting the Quality of Medicines (PQM) program, which was funded by the U.S. Agency for International Development, this course is readily accessible for anyone who works in medical products production and quality assurance. This includes manufacturers and regulatory authorities.

The self-paced course includes ten modules on GMP as it relates to:

  • Medicinal products (finished dosage form)
  • Active pharmaceutical ingredients (APIs)
  • Quality risk management
  • Deviations, root cause analysis (RCA) tools and corrective and preventive action (CAPA)
  • Validation
  • Qualification of facilities, equipment, and utilities
  • Data integrity and computer system validation
  • Auditing
  • Heating, ventilation, and air conditioning (HVAC) systems
  • Water systems

The course is self-paced, with each module taking approximately 30-45 minutes to complete.
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