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including the need for Notified Body involvement
EU & Helsinki Directives
Part 210/211 - cGMP in Manufacturing
Inspection of Medical Device Manufacturers 7382
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH 210 including the need for NotifiedThe GMP Parts 11 Electronic Records; Electronic Signatures along with the Drug GMPs Parts 210 and 211 Current Good Manufacturing Practice for Finished Pharmaceuticals regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. 21 CFR Part 11 Electronic Records; Electronic Signatures Part 11 Scope and Application August 2003 21 CFR Parts 210
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