The
new version of chapter 6 of the EU GMP Guide comes into effect on 1st
October 2014.
“Quality
Control is concerned with sampling, specifications and testing as well as the
organisation, documentation and release procedures which ensure that the
necessary and relevant tests are carried out, and that materials are not
released for use, nor products released for sale or supply, until their quality
has been judged satisfactory. Quality Control is not confined to laboratory
operations, but must be involved in all decisions which may concern the quality
of the product. The independence of Quality Control from Production is considered
fundamental to the satisfactory operation of Quality Control.”
The
final version includes of a new section on technical transfer of testing
methods and other items such as Out Of Specification results. There is also a
new section on the technical transfer of analytical methods.
Posted by Tim Sandle
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