USP: Verification Of Compendial Methods
By Dr. Tim Sandle
General Chapter <1226> Verification of Compendial Methods
The USP has proposed a revision of the General Chapter <1226> Verification of Compendial Methods (in the Pharmacopeial Forum November/December 2010).
The update aims proposes a change in the section marked "Verification Process", where the following paragraphs have been 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 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."
It is proposed that the following points are added to the list of items to be considered 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 target is to publish the revision of the General Chapter<1226> Verification of Compendial Procedures in the USP 35.
Tim Sandle, Ph.D, M.A., BSc (Hons), CBiol, MSBiol., MIScT – Dr. Sandle is the Head of Microbiology at the UK Bio Products Laboratory. Dr. Sandle is a chartered biologist and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. In addition, he is an honorary consultant with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester and is a tutor for the university's pharmaceutical microbiology M.Sc course. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is currently chairman of the PharMIG LAL action group and serves on the NBS cleaning and disinfection committee. He has written over eighty book chapters, peer reviewed papers and technical articles relating to microbiology. He is currently the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology forum (www.pharmig.blogspot.com). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.