Validating shortage annexes

Any approach to the Process Validation of Listed Complementary Medicines should be risk-based and consistent with Annex 20 - Quality Risk Management, of the .

Prior to validation it is expected that manufacturing equipment will have been appropriately qualified and that Installation Qualification (IQ), operational Qualification (OQ) and Performance Qualification (PQ) will have been conducted, to determine appropriate validation parameters (e.g.

Validation carried out during routine production of batches intended for sale.

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The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.

The documented verification that the facilities, systems and equipment, as installed and modified, comply with the approved design and the manufacturer's recommendations.

Note: The above definitions are reproduced here for ease of reference from Annex 15 - Qualification and Validation, of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products January 2009.

Top of page Process Validation for Listed Complementary Medicines should follow the general principles contained in the current Australian Code of GMP.

A Process Validation may also be conducted on three batches of different batch sizes, provided the same equipment is used, if these batch sizes are typical of the batch sizes that will be manufactured for a specific product or product group.

The Process Validation Protocol should be formally approved by appropriate senior personnel, including QA, before validation activities commence.Overages which are included into the manufacturing process (e.g.for stability purposes) should be included in the target assay for the purposes of Process Validation.A mechanism should be in place to evaluate what Process Validation is required for new product introductions.For existing, well-established products, retrospective validation could be considered.The documented verification that the facilities, systems and equipment, as installed and modified, perform as intended throughout the intended operating ranges.

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