Protocol: includes procedures and acceptance criteria
Report: documented results
Justification needed when non-pharmacopoeial methods are used (if pharmacopoeial methods are available). Justification to include data, e.g. comparisons with the pharmacopoeial or other methods
Detailed standard test methods include:
- chromatographic conditions, reagents and others
5. Method validation
5.1 Validation should be performed in accordance with the validation protocol.
The protocol should include procedures and acceptance criteria for all characteristics. The results should be documented in the validation report.
5.2 Justification should be provided when non-pharmacopoeial methods are used if pharmacopoeial methods are available. Justification should include data such as comparisons with the pharmacopoeial or other methods.
5.3 Standard test methods should be described in detail and should provide sufficient information to allow properly trained analysts to perform the analysis in a reliable manner. As a minimum, the description should include the chromatographic conditions (in the case of chromatographic tests), reagents needed, reference standards, the formulae for the calculation of results and system suitability tests.