GMP Documentation

Writing of QA, QC, Production, R&D and Corporate QA SOP’s Review and revision of existing SOP’s Audit to identify need for new SOP’s and prepare new SOP’s Preparation and review of packaging material and raw material specifications Preparation of quality manual and Policy for the company Preparation of Safety, health and environment related SOP’s Review existing MFR’s and revise to meet regulatory requirements Preparation of annual product review and trend analysis Preparation and revision of Site Master File Preparation and revision of Validation master Plan Review and revision of protocols for various types of validations Process Validation Analytical validation Cleaning validation Protocols for DQ, IQ, PQ and OQ for equipments Other GMP documents Review of documents and approvals from regulatory agencies to identify gaps and non compliances