Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good.
Standard Operating Procedure (SOP) for Review of Analytical Report and Raw Data. Analytical raw data is data generated during sample.
Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC..
Checklist for review of microbiology data generated during the different tests of microbiology i.e. Antibiotic Assays, Particulate matter test, BET.
The Acceptable Quality Level (AQL) is a percent defective that is the baseline requirement for the quality of the producer’s.
Checklist for review of analytical raw data generated during the chemical analysis of finished drug product, the raw material (API-Active.