When a product and process is designed, it should be demonstrated that the developed process is capable of consistently producing the product meeting the pre-determined specifications. The associated validation documentation, including the validation protocol and validation report, can be consulted during audits and inspections. ValserV has a lot of experience with Process Qualification and can provide you with this service.
Main activities process qualification
The Core of Process Qualification includes the following main activities:
- DQ – Design Qualification (does not apply for the medical devices)
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
Simply put it is verified if the equipment and processes meet the specified requirements (user, functional and design requirements). When the results meet the specified requirements and all is properly documented, the new or changed process can be released.