ICH Pharmaceutical Method Development and Validation
FDA GMP / GLP Pharmaceutical Analytical Laboratory needed Development and validation of the dissolution method with the flow-through apparatus for our final pharmaceutical product in accordance with ICH guidelines.
- Test should be performed according to Eur. Ph. monograph 2.9.42 (Dissolution test for lipophilic solid dosage forms).
- Validation of the method should be performed in accordance to ICH Q2(R1) guideline.
- laboratory should have a GMP or a GLP certificate.
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