This service is provided by a dedicated experienced team for each field, where the cGMP audit can be commenced upon corporate quality requests or a prior official inspection by a regulatory body or requested on regular basis to assure the continuous compliance and improvement for the benefit of business sustainability and cGMP Compliance.
We at PharMatrix can perform cGMP audit in different fields, including but not limited to (Production, Quality, Compliance, Engineering, Calibration, Validation, and Qualification). Furthermore, the regulations that will be followed will depend on the individual project, but as a minimum, PharMatrix will use the following Regulations & Guidelines:
- Saudi Food and Drug (SFDA) Requirements.
- Jordanian Food and Drug Administration (FDA) Requirements.
- Guidelines of the Gulf Central Committee for Drug Registration (Gulf Health Council).
- FDA Code of Federal Regulations.
- FDA guidance of Industries.
- European Commission EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.
- World and Health Organization Technical Reports.
- GMP Guidance for The Pharmaceutical Inspection Co-operation Scheme (PIC/S).
- Updated Guidance Documents published by the International Society for Pharmaceutical Engineering (ISPE).
- Updated Technical Report issued by Parenteral Drug Association (PDA)