This document’s objective is to provide guidance and suggest a harmonized approach within the API industry on how to manage suppliers of materials and services in an adequate and compliant manner.
The intention is to establish a supplier management framework that is not only compliant with the official requirements, but also covers other supplier management related aspects that play a role in real life, e. g. when dealing with suppliers that are reluctant to sign quality agreements or to accept
physical audits. Although these other aspects are important, little detail is covered in official guidances, a gap which this ‘best practices’ guide is aiming to fill.
Throughout this document, the term “Supplier” will be used to refer both to material suppliers as well as service providers (service suppliers).
The guide is based on the experience and best practices of the authors while working in the API industry. It has no legal base nor is it endorsed by any official regulatory body. It is therefore not a replacement of any official guideline but reflects APIC’s position on the topic.
In general, this guide focusses on supplier management of suppliers used for commercial production.
The same approach can be applied also for suppliers used during earlier development stages, although (following the risk-based approach) the API manufacturer might define less strict requirements. It is the common expectation that the level of detail and requirements increase with the process
development (e.g., preclinical, phase I, phase II, phase III), as such, not all the activities below mentioned may apply to all development stages.