CGA M-6

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CGA M-6 describes the minimum requirements for validating noncompendial analytical test methods. It also describes a method for establishing the equivalency of alternate test methods.

This publication is intended to meet the requirements of:

  • Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 211.165(e), 211.194(a)(2), and 820.72(a); and
  • Chapter 1225 (Validation of Compendial Methods) and portions of Chapter 621 (Gas Chromatography) in the USP?NF.

Product Details

Edition:
3rd
Published:
11/07/2019
Number of Pages:
13
File Size:
1 file , 630 KB

CGA M-6

Click here to purchase
This publication describes the minimum requirements for validating noncompendial analytical test methods. It also describes a method for establishing the equivalency of alternate test methods. This publication is intended to meet the requirements of:

– Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 211.165(e), 211.194(a)(2), and 820.72(a); and
– Chapter 1225 (Validation of Compendial Methods) and portions of Chapter 621 (Gas Chromatography) in the USP-NF.

Product Details

Edition:
2nd
Published:
08/01/2013
Number of Pages:
20
File Size:
1 file , 490 KB