Validating shortage annexes

14-Dec-2016 01:22

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.

Selection of both a vitamin and a mineral may provide additional assurance compared to selecting for assay only two vitamins or only two minerals.

When selecting ingredients for assay, the physical characteristics of a particular ingredient may need to be considered to ensure issues such as homogeneity are addressed.

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.

Selection of at least two ingredients that can be readily tested without interference from other components is generally acceptable for Listed Complementary Medicines.

Validation of a process for a product which has been marketed, based upon accumulated manufacturing, testing and control batch data.

However in recognition of the reduced risk generally associated with Listed Complementary Medicines and in acknowledgement that manufacturers may be manufacturing a large number of products with only minor differences in formulation, Process Validation requirements for Listed Complementary Medicines are not generally as stringent as for registered o TC and Prescription Medicines and Concurrent Validation is generally accepted for Listed Complementary Medicines.

Such justifications may be based on 'groupings' whereby products which have similarly constructed formulations and are manufactured on similar equipment are placed in a group.

For Listed Complementary Medicines that are (complex) mixtures of vitamins &/or minerals &/or herbs, the Process Validation Protocol should specify which ingredients will be tested as part of the Process Validation.

To confirm the effectiveness of the process it may not be necessary to test all vitamin or mineral ingredients in the same product, as results on multiple ingredients do not generally provide a lot of additional assurance that the manufacturing process is valid.

Validation of a process for a product which has been marketed, based upon accumulated manufacturing, testing and control batch data.However in recognition of the reduced risk generally associated with Listed Complementary Medicines and in acknowledgement that manufacturers may be manufacturing a large number of products with only minor differences in formulation, Process Validation requirements for Listed Complementary Medicines are not generally as stringent as for registered o TC and Prescription Medicines and Concurrent Validation is generally accepted for Listed Complementary Medicines.Such justifications may be based on 'groupings' whereby products which have similarly constructed formulations and are manufactured on similar equipment are placed in a group.For Listed Complementary Medicines that are (complex) mixtures of vitamins &/or minerals &/or herbs, the Process Validation Protocol should specify which ingredients will be tested as part of the Process Validation.To confirm the effectiveness of the process it may not be necessary to test all vitamin or mineral ingredients in the same product, as results on multiple ingredients do not generally provide a lot of additional assurance that the manufacturing process is valid.A mechanism should be in place to evaluate what Process Validation is required for new product introductions.