Dear All,
Good day.
Looking for your kind help in following issue.
We know that Trial batch (lab batch, pilot batch, validation batch) or any type of small batches for trial are conducted by Product development dept. / RLD in presence of QA.
I want to know that is there any authority of Production people to conduct trial of their own. Suppose production want to manufacture small trial batch for their own study. Is it allowable for them.
In our industry production people are engaged in commercial manufacturing only. Trial manufacturing in done by PD.
Please help in reference to clarify that trial batch is only to be conducted by PD not production & Production people will be engaged in commercial miniaturing.
Most pharma companies have F & D departments , they are authorized to do the trial batches, but these department has to be at a different location than the production site.
thank you for your reply. so routine production people cannot conduct trial/ development study of their own. right? please help in reference if possible.
I have been in this industry from past 10 years . I haven’t seen production department doing their own study. For this purpose companies hiring people for F&D and R&D to do this type of study . I hope this will clear your doubt.