A cGMP Program Compliance and Gap Analysis
Perform cGMP compliance and Gap analysis
- Area: Saskatchewan – Saskatoon, Regina
- Project Type: Auditing
About this Project
OBJECTIVE
Assess that client’s quality systems are in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices.
SERVICES
This client uses PSC® Biotech’s professional services group to perform cGMP Compliance and Gap Analysis on their operations. The main focus was to assess the quality systems are in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices and to determine if the operation is in a “state of control “. The PSC Biotech® Services Project Manager worked with the clients Quality team to assure that the clients specific quality concerns were incorporated into the gap analysis process. PSC® performed cGMP Program Compliance and Gap Analysis and recommended improvements and upgrades to quality systems. PSC® prepared and advised on cGMP compliance programs including Non-conformance investigation and Corrective Action and Preventive Action procedures and the regulatory requirements.
PROJECT SUCCESS:
The project was successful, and the company is still a client of PSC®.
Related Projects
20 Years & Counting of CQV Services
Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.
Cleaning Validation & Decommissioning Project
PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.
Sterile Fill/Finish Laboratory Facilities CQV Project
The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.
How Can We Help You?