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
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 In this draft
guidance FDA now advises a combined approach.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
Dr Günter Brendelberger