RE: RE: variation of std batch size. Contribution from JD Mallet written on 9/4/2010 at 17:09
Original contribution: RE: variation of std batch size. written by Venkatesh S Rao on 9/4/2010 at 14:00) Your question may probably receive slightly different answers according to the regulatory authority of the destination market. In preamble I will consider that you will use the same train of equipment for the new batch size.
In shape the current industrial batch size of a batch should have undergone sucessful documented validation. From the report of the validation you should be able to read what are the critical aspect of the process. Ideally you will have validated two batch sizes with the same train of equipment and you will have a range of variation possibility within these two sizes. If not, the following should normally apply :
First, you should know if the planned batch size change enters into that category of risk or not. If, yes, you will have to fully revalidate the new batch size. If not, you may simply proceed with a verification of the consistency of new batch size.
Hope this will help. Any other view from the Forum ?
Answering this Contribution:
|
