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Part 114 - Acidified Foods
EU & Helsinki Directives
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
or Holding Operations for Dietary Supplements
including the need for Notified Body involvement
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH 210 Part 114 - Acidified FoodsThe 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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