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FDA compliance in research and control laboratories

Technological innovations and an appropriate methodology help opening new markets
: Huen, J.

GIT laboratory journal (2001), Nr.4, S.167-168
ISSN: 1434-2634
Fraunhofer IPA ()
Food and Drug Administration; FDA; compliance; laboratory; CFR; Code of Federal Regulations; Laboratorium

As working for the United States is the ambition of more and more European companies in a global market, the topic of FDA compliance is gaining importance. The regulations issued by FDA can be found in the Chapter 21 of the US Code of Federal Regulations. Compliance can be reached through a systematical work involving identification of applying requirements, training of personnel, reorganization and documentation. What is more, the use of innovative equipment both simplifies the implementation of the new working methods and brings a high level of reliability. Fraunhofer IPA works as an independent expertise center on the technological and organizational aspects of FDA compliance.