PCS performed a five-day GMP audit of Zentiva a.s. Hlohovec and Zentiva a.s. Prague, to determine the GMP compliance status of the company. Topics included;
- general organisational matters
- review of facility layout
- review of quality systems
- warehouse and logistics
- manufacturing processes associated with the manufacture of selected APIs
- equipment qualification, calibration and maintenance
- general documentation (e.g. BMRs, SOPs, specifications, etc.)
- batch record review of selected lots manufactured
- Operator training and qualification procedures
- Self-inspection and CAPA processes
- Change control
- Failure investigations
- Deviation management
- Complaint management
- Site utilities, as appropriate
- Process validation, as appropriate
The audits were conducted against U.S. FDA and EU GMP guidelines.
In addition to the audits, PCS rendered assistance with the Computerized Systems Validation (CSV) program of Zentiva. The activities included:
System identification: Identify all computerized systems used throughout the company. Analyze computerized system risk: Perform a holistic risk assessment on each computerized system to define the GMP priorities. Reduce risk: Analyze each computerized system and where possible take basic steps to reduce the risk of the computerized system.
- Update: Revise the priority listing to reflect any changes in GMP criticality.
Create summary overview: Make a simple presentation of each system showing the business process, system history, validation activities and future plans.
In addition to this, PCS assisted with the review and improvement of the QMS SOP's surrounding the computerized systems validation.
