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ICH Q7 - GMP Std Handbook:
Chapter 3 - Premise and Equipment
Part 11 - Electronic Records with Scope and Application 2003
European GMP Regulations
Annex 19 - Reference and Retention Samples
EU cGMPs for ATMP with EU GMP Chapters 1-9 58 ICH Q7 - GMP StdEudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products In Operation: 22 May 2018 Advanced therapy medicinal products that are administered to patients under Article 3(7) of Directive 2001 83 EC1 (so called hospital exemption) must be manufactured under equivalent quality standards to the manufacturing of
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