Supplier qualification

The good manufacturing practice (GMP) environment requires qualification of suppliers to ensure drug quality and safety. The EU GMP Guidelines as well as ICH Q10 and the national AMWHV (German Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients, Arzneimittel- und Wirkstoffherstellungsverordnung) specify requirements for assuring quality of the product between the customer and contractor or supplier. In addition to suppliers of goods (manufacturers and intermediaries of starting materials, active ingredients and excipients; contract manufacturers of intermediate and finished products, packaging materials, plants, systems, spare parts, computer systems etc.), suppliers of services (with regard to calibration, maintenance, repair, pest control, storage, logistics, transport, distribution, development, manufacturing, testing, release, archiving, cleaning, clothing, consulting, third-party audits, etc.) must also be assessed in this context.

The aim of supplier qualification is, on the one hand, to safeguard supply chains throughout the product lifecycle and, on the other hand, to ensure robust internal processes in compliance with the relevant regulatory requirements.

Supplier qualifications are risk-based, with the scope and depth of the assessment depending on the process-specific risk level.

As part of risk management and on the basis of regulatory requirements, audits must be carried out by adequately trained personnel from the manufacturer or by third parties on site at the supplier's premises or by means of questionnaire audits, depending on the criticality of the goods/services. Furthermore, already qualified suppliers must be regularly re-evaluated or requalified.

Assured supply chain with qualified suppliers and robust processes is ultimately the basis for reducing complaints and ensuring medicinal product safety.

Thus, all supplier qualification actions contribute to the overall goals of medicinal product safety, efficiency and compliance.


  • EU GMP Guideline, Parts I and II
  • ICH Q10 Pharmaceutical Quality System