Selection of at least two ingredients that can be readily tested without interference from other components is generally acceptable for Listed Complementary Medicines.When deciding what ingredients to assay for, there may be little benefit in assaying for a Process Validation an ingredient in a product that constitutes more than 50% of the dose unit.
When designing the Process Validation acceptance criteria, the targeted limits should reflect a plus and minus percentage of the added dose and should be chosen to demonstrate the robustness of the process.For example, if a tablet containing 1000 mg Ascorbic acid had a 20% overage added for stability purposes, assays conducted for Process Validation purposes should be based on an Ascorbic acid content of 1200 mg per tablet.Technical Working Groups have been established by the TGA's office of Manufacturing Quality (OMQ) to bring together manufacturing technical expertise from industry and the regulator to address the application of the Guidance documents are not intended to establish a minimum standard of practice for audit purposes. This Guidance is not mandatory or enforceable under law. It describes a way that a manufacturer may operate to demonstrate compliance with the relevant Code of Good Manufacturing Practice for Medicinal Products This document is provided for guidance only and has been developed on the basis of current knowledge of the subject matter.It should not be relied upon to address every aspect of the relevant legislation.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 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.The documented verification that the facilities, systems and equipment, as installed and modified, perform as intended throughout the intended operating ranges.The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.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.