CGA M-11

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CGA M-11 is intended to help manufacturers implement modern quality systems and risk management processes and to incorporate quality by design principles that meet the current good manufacturing practices (CGMP) requirements in Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 210, 211, 820. An effective quality system helps to ensure compliance to guidance and regulation.

This publication provides guidance on how a medical gas, device gases, and device manufacturers can implement the quality systems approach to meet requirements of 21 CFR Parts 210, 211, and 820.

Product Details

Edition:
3rd
Published:
03/15/2021
Number of Pages:
16
File Size:
1 file , 310 KB

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CGA M-11

Click here to purchase
This publication provides guidance on how a medical gas manufacturer can implement the quality systems approach to meet requirements of 21 CFR Parts 210 and 211. It is based on a review of the FDA’s September 2006 Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations.

Product Details

Edition:
2nd
Published:
07/01/2014
Number of Pages:
16
File Size:
1 file , 1.1 MB

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