Hello members
what requirements must be present for the production environment management system
Best regards
1.GMP & Compliance
2.Nature of Products made and OEL’s
3.Contaiments
4.Sensitivity of product to heat.
5.Final product Quality parameters(Microbial load, Endotoxins, Particulate matter)
Dear Sir,
We are currently in the qualification process of new equipment from to a New manufacturing Unit. These equipment do not have URS, but have DQ, IQ, OQ, and PQ documents from supplier end . Do I need to create retrospective URS for the equipment before performing the IQ/ OQ / PQ from supplier document? .
So I presume that since there’s an OQ, there is some kind of functional requirements spec.
The user spec would then be any customizations plus any specifications for your intended use.
An oven example comes to mind. Maybe the functional spec (done by the provider) says the oven will maintain a temperature within some tolerance of the range of setpoints. Your use, though, may be putting something cold in the oven so you may have a requirement to get back to the setpoint within a certain amount of time. This, only you could verify.
And for their PQ, maybe they have confirmed the system operates at spec for 12 hours but maybe your application requires 24 hours.
If you absolutely just purchase a system out of a catalog and everything you do is within the (already proven) scope of the manufacturer’s validation, then you probably don’t need a URS. However, you should document all this and provide risk-based justification for everything you (don’t) do.