Sunday, 18 May 2014

EU GMP Chapter 6: Quality Control

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.

For details see A3P

Posted by Tim Sandle