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EMA: Regulatory and procedural guideline: Concept Paper on the Revision of Chapter 6 of the EU GMP Guide Quality Control, draft.

23.11.2010
Chapter 6 of the EU GMP guide provides general guidance on the Quality Control Department and Good Quality Control Laboratory Practice including specific aspects for documentation, sampling and testing. General aspects for premises and equipment, documentation and the use of contract laboratories are linked to Chapters 3, 4 and 7, respectively, of the EU GMP guide.

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