Supplier Qualification and Management Guideline | APIC

Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy.

This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines.

The cGMP regulations for final medicinal products are clearly defined in each country and region.

The content of the regulations may vary but the objectives are the same The scope of this guidance document is to share the best practices of APIC member companies on systems to be implemented to adequately manage suppliers through the complete life cycle of the product, including Supplier Selection Process based on definition of the User’s Requirements for a material with as a minimum a specification -

  • Sample evaluation including where necessary laboratory and /or production trials,
  • Due Diligence process of potential suppliers of critical raw materials, registered intermediates and APIs,
  • Quality Assessment of all suppliers,
  • Change control and production assessment as necessary,
  • Supply chain security,
  • Ongoing monitoring and evaluation.

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