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