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At ASI, the method validation process includes the following steps:
- Establishment of the intended use of the method and its performance requirements
- Definition of the analytical method to be validated (this may involve preliminary method development activities)
- Development of a specific validation protocol, including descriptions of the parameters to be assessed, test procedures and criteria for results
- Approval of the validation study protocol by ASI and the client
- Performance of the study as described in the protocol, and verification that the results for all tests meet acceptance criteria
- Quality Control (QC) of all data
- QA review of a draft validation report and the associated data (if GMP compliance is required)
- Completion of the validation report
- Revision and finalization of the method, incorporating any aspects of the method confirmed or discovered during the validation study (for example, if the stability of standard solutions was assessed during the validation, expiration limits for standard solutions may be included in the final version of the method)
Because the design of a validation study is dependent on the method type, it’s intended use and the specific method requirements, ASI develops specific validation protocols for each validation study.
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