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Group Ich Q7

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Q7 Implementation Working Group ICH Q7 Guideline: Good ...

Q7 Implementation Working Group ICH Q7 Guideline: Good ...

database.ich.org

the ICH Q7 Glossary [ICH Q7, Section 20] refers to the activities, not the organisational structure. For examples of quality responsibility related to testing and release, refer to [ICH Q7, Sections 2.13, 2.22, and 11.12]. Appropriate laboratory controls should be followed [ICH Q7, Sections 11.10, 16.10] regardless of who performs the testing.

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ICH HARMONISED TRIPARTITE GUIDELINE

ICH HARMONISED TRIPARTITE GUIDELINE

database.ich.org

ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS Q7 Current Step 4 version dated 10 November 2000 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the …

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