According
to A3P, a draft version of EU GMP Chapter 6 has been issued.
Principle:
This
chapter should be read in conjunction with all relevant sections of the GMP
guide 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.
Reasons
for changes:
Inclusion
of a new section on technical transfer of testing methods and other items such
as Out Of Specification results.
Posted by Tim Sandle
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