As the last step in the process of building a production plant, and once all of its facilities and production and installed machinery are finished, you need a full program of commissioning and validation of all components in order to ensure that all processes, equipment and facilities operate according to the specifications.
The entire process should be properly documented according to international standards in order to facilitate the approval processes of local and / or international pharmaceutical authorities.
- Reception and commissioning of all facilities and equipment
- USR´s definition
- Validation Master Plan (VMP)
- Validation IQ / OQ / PQ
- Management of Technical Documentation
- Approval of pharmaceutical, local authorities, EU GMP/ FDA ….