GMP Regulatory Services
- Writing of QA, QC, Production, R&D, and Corporate QA SOPs.
- Review and revision of existing SOPs
- Audit to identify the need for new SOPs and prepare new SOPs
- 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 SOPs
- Review existing MFRs and revise them 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
- Protocols for DQ, IQ, PQ and OQ for equipment
- Other GMP documents
- Review of documents and approvals from regulatory agencies to identify gaps and non compliances