Qualification and validation are fundamental elements of a quality assurance system. Their purpose is to provide evidence that manufacturing and quality control facilities, equipment, and procedures are adequate for their intended purpose, and that they ensure the required quality of the pharmaceutical excipients manufactured. Though ISO 9001 does not spell out those demands, they are clearly defined in the IPEC-guidance documents.
With our long-standing experience in facility and equipment qualification, as well as the validation of production and cleaning processes, we gladly advise and support You in all questions and tasks to be tackled in Your work context. We not only help You to effectively plan and realize risk-based and GMP-conform qualification and validation. We also support You in preparing straightforward, concise and comprehensive documentation that will be well presentable in inspections and audits.
Our service comprises:
- Risk analysis according ICH Q9 (EU GMP guidelines part III) for identification and definition of required qualification and validation activities
- Support in planning, coordination and realization of qualification and re-qualification tasks as well as process and cleaning validation activities
- Performance of calibrations as required during qualification activities
- Preparation of master SOPs for qualification, process and cleaning validation
- Preparation of a qualification master plan
- Training of employees