Over the past decade, supply chains within the pharmaceutical industry have become increasingly complex. This is a result of a growing outsourcing trend, combined with a supplier base that is more and more spread from a global perspective.
This situation makes API manufacturers more dependent on their suppliers and more vulnerable to supplier related risks. These risks are not only limited to quality or compliance issues, also business continuity or reputational risks can be a result of poor supplier management.
To manage such risks, risk management (see also ICH Q9) is becoming an integral part of today’s supplier management processes. In addition, regulatory agencies nowadays focus more on how suppliers are managed, and pharmaceutical customers of API producers expect their API manufacturers to have adequate supplier qualification and evaluation programs in place.
This Guide provides a framework for API manufacturers to implement an adequate, robust, risk-based supplier management process.
This guideline looks at supplier management primarily from a quality perspective (i.e., materials or services potentially affecting quality). However, it also briefly touches, for the materials or services in scope, other non-quality related aspects (e. g. REACH, carbon footprint, CSR…). The reason is that in many cases different aspects cannot be seen independently when it comes to fulfilling the objective of having a reliable and stable supply base.
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.
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.
The principles of the guide can also be used in case materials or services are purchased on a contract manufacturing or contract development basis (CMO, CDMO).
