Blue Sky Approach - Down to Earth Solutions
Analytical Laboratories are required by regulatory authorities to provide documentation to confirm they are qualified to run validated, analytical methods. The qualification process usually involves the laboratory running the method to produce sufficient data, which show the results obtained are reliable, accurate and precise. The documentation of this procedure usually takes the format of a method transfer or verification report. Recommended parameters for the transfer of methods and technical issues that may arise during transfer will be discussed. Personal experiences and problems encountered during method transfer of analytical methods are welcome for open discussion.
Verification of Compendial Methods
Compendial methods are published methods that are accepted to be the legal standard in the country to which the Pharmacopeia belongs (USP, EP, BP, JP). In 2006 the USP published general chapter <1226> - a guide to the verification of compendial procedures. Compendial methods have a reputation of not working on the first attempt. A reason for this may be that the method is being used for a different formulation than it was validated for or the method may have been validated prior to the validation revolution in 1999/2000 in which case the validation will not stand up to a present day audit or operate correctly on new equipment. Hence the need for method verification.
The intent of verification is to show that a laboratory can produce data as evidence that the method can produce reliable data for its intended purpose under the actual conditions of use.
This course discusses the technical challenges of verifying a compendial procedure, reviews examples of the amount of verification required for a typical monograph and the regulatory requirements that need to be in place to ensure the method is verified to be suitable under actual conditions of use.
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