Test Method
Validation Support
- Method validation support in accordance with PTI-supplied USP <1207> protocol
- System suitability testing
- On-site execution support with a PTI engineer
- Consultation calls for execution review
Following the successful completion of test method development, PTI offers end-to-end support
for method validation to ensure your container closure integrity (CCI) method meets
regulatory and quality standards. A validation protocol template, compliant with USP
<1207.1>, is provided. This protocol outlines a structured approach to executing the
validation and serves as a working document for recording and documenting each stage of the
process. It enables a standardized and efficient execution of validation activities while
maintaining traceability.
The method validation process is designed to thoroughly evaluate critical performance
characteristics, including accuracy, precision, intermediate precision, specificity,
detection limit, quantitation limit, range, and robustness. Execution is supported
on-site by a qualified PTI engineer to ensure proper implementation. After completion, a
consultation call is held to review the results, address any findings, and finalize
documentation.
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