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A URS should not cover just the current GXP requirements (GMP, GAMP, GLP, GCP and GDP) and those of the registered process(es), i.e. the pertinent parameter set-points and tolerances from the Production Rationale, it should be expanded to become a receptacle for all required deliverables so that the risk of any area of non-compliance, be it with regulatory requirements or corporate standards, can be formally assessed, minimised and, where appropriate, accepted.

Any proposed changes to a URS, arising from discussions with a prospective vendor following issue for tender, should follow the same formal assessment and approval process as the original document before being officially incorporated.

If you need any help in devising a format for URSs, or in the compilation or risk assessment of URSs, then you would definitely benefit from a few hours of ViP consultancy.

Whatever you need, we can help. CONTACT US  to find out how.