EDQM has published a companion text to the general chapter 5.26, Implementation of pharmacopoeial procedures, which provides examples of risk assessments for the implementation process, applied to a variety of different types of analytical methods. The risk assessments are an excellent resource, not just for method verification but also for other lifecycle management activities, such as post approval changes and transfer.
The examples provided are for the following methods:
A. IDENTIFICATION BY INFRARED ABSORPTION SPECTROPHOTOMETRY
B. RELATED SUBSTANCES TEST BY LC-UV
C. ASSAY BY LC-UV
D. POTENCY BY CELL-BASED ASSAY
E. MICROBIAL ENUMERATION
F. SULFATED ASH
The risk assessments for these selected methods should enable application of the principles to other types of methods and technologies.
The document (EXAMPLES OF IMPLEMENTATION OF PHARMACOPOEIAL
PROCEDURES ACCORDING TO CHAPTER 5.26 “Implementation of pharmacopoeial procedures”) is accessible via the Knowledge database entry for general text 5.26 (under Additional Information).
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A full discussion of the implementation of pharmacopeia methods is included in our courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘, and ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘.
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