In my company, we are currently discussing our options to setup a brand new GMP cleanroom.
One set of stakeholders, believes that we do not need formal validation, that instead we can use previous particle count testing, air flow testing, etc, as evidence that the cleanroom is ready to be used for GMP manufacturing.
Another set of stakeholders, believes that a validation protocol is needed, along with all the requirements of a typical validation protocol, which include testing procedures.
According to your experience with GMP cleanrooms, what has been the approach?
Is there any flexibility if the company is in Phase 1?
Thank you!!
If you build a new clean room there will be great difference between the old or existing facility and new construction.
The best approach as per GMP is to plan a clean room with a set of parameters. Once you have that set of parameters inked in your URS and later DQ etc you must have a validation master plan. Then comes the real time validation and monitoring procedures.
You must have a new set of validation protocols.
Design qualification is very essential for such GMP clean rooms.
Regarding the flexibility of a clean room for Phase -1-- I can only say if your products are not Hormones, Antibiotics, Antigens, Biologicals ,Immunosupressents and Anti neoplastic (Oncologicals) products.There is no flexibility for these products.
The reason is these are cosnidered as investigational Medical products and FDA looks very deeply into manufacturing.
Any futher questions if you have please ask.I shall reply back very soon.
Regards