It is a requirement of GMP that material should be purchased from approved suppliers and manufacturer has a particular and thorough knowledge of the suppliers. 


Supplier qualification should include an evaluation on the reliability of the suppliers to supply materials of consistent quality with adequate evidences. 


An integrated supplier qualification program should also identify and mitigate the risks associated with material in question. 


Therefore, it is the responsibility of GMP manufacturer to establish a robust supplier qualification program. Assessment of suppliers with supporting evidence should be formally documented and should be available during GMP inspection.


This guideline is intended to provide general guidance on the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (“the GMP Guide”) and the relevant Annexes, in particular Annex 2, with respect to managing suppliers of starting materials and raw materials where applicable. 


This document is developed on the basis of current knowledge of the subject matter and should be regarded as for guidance only. 


It is not mandatory under law. It is not intended to create additional requirements or to form the basis for GMP inspection.


There may be other acceptable approaches in providing a good level of quality assurance that materials used to manufacture pharmaceutical products are procured from a reliable source and are of appropriate quality.


This guidance is applicable to managing all suppliers who provide starting materials (active pharmaceutical ingredients (APIs) and excipients) to manufacturers for the manufacture of pharmaceutical products, including investigational pharmaceutical products. 


It is also applicable for suppliers providing raw materials used in the manufacture of advanced therapy products (ATPs”).


Important: The term ‘supplier’ in this document refers to any entity supplying starting materials and raw materials to manufacturers of pharmaceutical products, such as:

- distributor;

- broker;

- agent;

- actual manufacturer of materials; or

- blood or tissue establishment for cell or tissues used as starting materials or raw materials for ATPs.