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Verification of Compendial Procedures - Changes Planned in the USP General Chapter <1226> -USP 35

 
In the Pharmacopeial Forum from November/December 2010, the USP proposed to revise the General Chapter <1226> Verification of Compendial Methods.
 
Changes planned are as below. USP planning to implement in USP 35.
  • The word "method" should be replaced by "procedure"
  • Aims to clarify the purpose and the scope of the verification process. "The verification process for compendial test procedures is the assessment of whether the procedure can be used for its intended purpose, under the actual conditions of use for a specified drug substance and/or drug product matrix."
  • "The process of assessing the suitability of a compendial analytical test procedure under the conditions of actual use may or may not require actual laboratory performance of each analytical performance characteristic."
The following will be added to the points which must be taken into consideration for the Verification of Compendial Procedures:
  • drug substance's synthetic route
  • method of manufacture for the drug product
  • effect of the matrix on the recovery of impurities
  • suitability of chromatographic conditions and column
  • appropriateness of detector signal response
The revision of the General Chapter <1226> Verification of Compendial Procedures should be published in the USP 35.
 
Clarification not provided by USP is "Whether the laboratory needs to prove the performance of each validation parameter for the assessment is left open".

Analytical Method Development
 
 
 
 
 
Analytical Method Validation
 
 
Validated analytical method only can give accurate results. Validation of analytical method is must for pharmaceutical analytical laboratory.
 
There is guideline for analytical method validation from ICH & US FDA.
 
 
ICH-Q2(R1)- Validation of Analytical Procedures - Text and Methodology
 
 
 
US FDA draft guidance on analytical procedures & method validation
 
 
 
EDQM guideline
 
 

Analytical Method Transfer

There is no definite guidance from USFDA on this subject. Recently USP has come up with a stimuli article on this subject. For more information refer the link below.
 
Transfer of analytical procedures-A new general information chapter
 
 
WHO draft guideline - Refer page 14 
 
 
 
 
 
 
 
 
 
 
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