Quality Management

Material Quality Control – Testing of raw imported bulk and packaging components, in-process, semi-finished and finished products. Documentation – Preparation of Technical Dossiers, Master Batch Documentation, Manufacturing/ processing instructions and Packaging orders, Validation documents, Test Methods and Specification sheets.

Validation – Process and Non Process Validation (equipment, facility, and utility systems including cleaning validation), Method Validation, Method Development and Verification, Computerized System Validation Product Release – Batch record review to appropriately determine satisfactory conformity to its finished products specification prior release. Product Evaluation – Stability testing, Annual Product Review, Pharmacovigilance and Handling of Product […]