Analytical documentation quality assurance review

Phase 5. Quality Assurance Project Plan (QAPP). A detailed QAPP was developed for review by GLNPO. The QAPP documented all sampUng and analytical chemistry procedures and health and safety concerns. 

Automated systems Process validation of unit-operations Cleaning methods Analytical methods Furthermore it must be assured that relevant documentation is up to date and available. If data from Product Quality Review (PQR, see Sect. 35.6.11) and stability testing are available they should be evaluated in order to identify any critical aspect of the processes. If not available related quality indicators, such as test results, deviations and complaints should be evaluated. 

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