The draft of the FDA Guidance for Industry Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations published in September 2004 covers the question of how to check the quality of materials, such as components, packaging materials or closures.

The American cGMP regulations require that either separate tests have to be carried out or values of the suppliers' certificates of analysis can be adopted on the condition that at least the identity of the material be checked additionally. In case the pharmaceutical manufacturer adopts values of certificates, he has to ensure by means of his own tests or examinations that the specifications on the suppliers' certificates of analysis are reliable.

FDA justifiably points out that, in contrast to this, modern quality management systems require regular audits at suppliers. Through these audits the pharmaceutical manufacturer can check if analytical tests and examinations are carried out reliably by the supplier. In this draft guidance FDA now advises a combined approach. It suggests for example that the manufacturer regularly conducts analytical examinations to verify the results listed on the certificates of analysis AND at the same time audits of suppliers.

This means that the topic supplier audit is now emphasised more than before by the FDA.

The question of how to reduce incoming goods inspections of packaging materials and the implied requirements for supplier audits will be an important workshop topic at our international ECA Education Course  "Quality Testing of Pharmaceutical Packaging Materials". This seminar takes place in Berlin from 20 - 21 April 2005. You will find the programme here.

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG