Can we used matrix approach in the process validation? if yes can some one give me the reference and example please
Currently no guideline has established yet and it is not advisable to go for matrix approach for PV.
Dear Ilu,
I have answered this query earlier in my post.
It is preferred that the batches made should be the same size as the intended batch size for full scale production for process validation But there is one more approach which is called matrixing approach This may not always be practical that batch sizes made same sizes as the commercial batch size, due to a shortage of available starting materials and in such cases the effect of the reduced batch size should be considered in the design of the protocol. When full scale production starts, the validity of any assumptions made should be demonstrated. This is an example of minimum batch size.
In some cases the batch size can be changed up to 10% with the on-going study by using the same equipment this is an example of maximum batch size. Matrixing by batch size is permitted if using the same equipment.
[process must be validated for the smallest and the largest batch sizes] reference The 2002 Australian Code of GMP refers to the Australian Code of Good Manufacturing Practice for Medicinal Products, 16 August 2002 http://www.tga.gov.au/docs/html/gmpcodau.htm. Annex 15.
I hope it may clear the matrix approach in PV with relavent guidelines.
If you have further query, please ask freely,
E mail address: shahnawaz.sajid@yahoo.com
Regards
Many thanks Shahid and Shahnaw for your quick reply