21 CFR Parts 210/211 - Drug GMPs with ICH Q7 GMPs for APIs

21 CFR Parts 210/211 GMPs for the Drug Industry

The GMP 210/211 regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

ICH Q7 GMPs for Active Pharmaceutical Ingredients is a worldwide harmonized GMP guideline for active pharmaceutical ingredients (chemical and biological), which covers all GMP aspects of manufacturing, quality control and trading. ICH Q7 - GMP for APIs This document was abstracted by the International Conference of Harmonisation (ICH).

This is a great training and information tool to provide all employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing.

They fit neatly into your pocket. (size 3.75" x 6.25")

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