Facility Qualification and Validation are expressly required by regulatory such FDA, WHO or even local organizations. Qualification establishes the confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances, and that finished products produced through a specified process meet all release requirements.
Validation provides the documented evidence of that fact.
To provide this evidence, every project will require a comprehensive documentation package that should consist of the following main documents:
- Validation Master Plan (VMP)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process Validation
During the validation process the responsibility for development and issuance of OQ and PQ even Process Validation is normally in the owner side. In regard to design and construction of the facility the focus of the Lirok activities will be on the master plan, DQ, IQ and some parts of OQ.
Lirok can support clients to prepare required documents, protocols and also doing required test according to defined procedures even issuing test rports etc.
Full package till the parts of OQ will provide by Lirok to ensure clients of a acceptable job in regulatory point of view.