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GMP Published

Chapter 6: Quality Control

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.

Organizations:
EMA

Version Timeline

Chronological release history

Ares(2014)968036 - 28/03/2014

Version milestone

Published

Publication Date

Mar 28, 2014

Effective Date

Mar 28, 2014