Audit Requirements for Analytical Method Validation and Transfer-few considerations.
Analytical Method Validation
- The audit inspector expects well written analytical methods that were developed based on scientific knowledge of the chemistry for both drug substance and drug product.
- Inspector expects latest and revised laboratory’s validation protocols and reports.
- All the validation protocols and reports should documented in specific format, well defined in approved SOP. Validation protocols for each method validation, specifically written for each method and specifying the steps to be used in validating the method
- Written reports, which correspond to the associated protocol, that contain the results of the validation and any deviations and/or failing results must be easily available during audit.
- The results, or the justification for omission (if any), should be included in the analytical report.
- Validation results must be thoroughly, clearly, and accurately reported. The associated raw data available should be available for review.
- The Validation Report should be cross checked, reviewed and approved with competent authorities; deviation and investigations if any should be included in the report.
Analytical Method Transfer
- Method transfer procedure must be clearly and accurately outlined in a protocol along with associated data reviewed prior to issuing a report. When complete, it must be indicated that the transfer was clearly reported, reviewed, and approved (Relevant certificates).
- Analysts in the receiving laboratory should receive training before using the transferred method (May be done as part of Intermediate Precision during validation).
- For method transfer, obtain feedback from the testing lab and incorporate these comments and observations in the method.
- At a minimum, conduct an Annual review of the method, data trending, related to the method and analyst feedback. (updated on 7/10/2020).
