Quality Control & Assurance
Your Partner in Pharmaceutical Regulatory Service- To design an appropriate Quality Management System (QMS)
- To implement any corrective and prevention actions
- To review and approve all documents (e.g. Validation and Test Plans, Test Protocol and Validation Summary Reports…), Validation Master Plan.
- To review and provide approve Standard operating procedures.
- Quality service according to guidelines stipulated by regulatory bodies.
- Independent review of DATA
- Comprehensive review of calibration procedures;
- Review of Laboratory Investigation Procedures for Deviation and Out of Specification handling meeting FDA regulations.
- Implementing Effective Internal audit program with effective CAPA system.
- Co-ordinating inspections and audits by regulatory bodies and customers
- Database audits
- Site qualification/audits
- Quality Systems audits