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In the Pharmacopeial Forum from November/December 2010, the USP proposed to revise the General Chapter <1226> Verification of Compendial Methods. The word "method" should be replaced by "procedure" where appropriate. This revision aims at clarifying the purpose and the scope of the verification process. In the paragraph "Verification Process" the following sentence will therefore be added: "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 question whether the laboratory needs to prove the performance of each validation parameter for the assessment is expressly left open: "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. Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy
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