The owners of Pharmaceutical production facilities are responsible for the Validation of the process and the automation systems. However a lot of the work, required for the validation of an automation system, is done by the supplier of that system.
It is always an option to redo all the validation work after the system is delivered, but a lot of time and work can be reduced by leveraging the documents of the supplier. Leveraging the supplier documentation is only possible when the quality of the supplier documentation is up to the standards of the user. The following measures can be taken to ensure the supplier quality:
- audit the supplier
- train the supplier in your quality system
- learn from the supplier
- agree (approve) on the Quality and Project Plan of the supplier
- define clear responsibilities between the companies
- aprove supplier specification, test protocols and test results
- monitor and assist the supplier during the total project
Most supplier have a different test approach compared to a Pharmaceutical company. Suppliers often are used to do an internal test, followed by a Factory Acceptance Test (FAT) and a Site Acceptance Test (SAT), while Pharmaceutical companies perform Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualifications (PQ). In stead of forcing the supplier to follow the IQ, OQ, PQ approach, it is more efficient and effective to let the supplier follow his own approach with his own standard protocols. When the quality department of the Pharmaceutical company approves these protocols in advance and the results after the tests, these documents can be leveraged for the validation. The Pharmaceutical Company uses its own approach, but the qualification protocols can be very simple, since most of the tests are already done and documented by the supplier. In the qualification protocol references to the tests of the supplier are made in stead of describing the tests. To ensure that all requirements are tested a Traceability Matrix is used.