hello sir what was the flow of change control like after technology transfer documents or R&D (DDR) are completed and handover to the site. what type of batch manufacturing we can start like scale up, optimization, pre-exhibit, trial and what type of change control we have to initiate to proceeding with QMS system like if we take a optimization batch based on DDR then which category of change control (i.e., Temporary or permanent) we have initiate. and after outcome of the study when we start the exhibit or submission batches again which type of change control we need to initiate either temporary or permanent and when it will be closed. please reply soon. thanks.
Change control should be initiated before the Technology transfer is started. As per the change control the TT meetings should be arranged. Hope this will clear your doubt.
@@hitendrakumarshah3718 thanks for your reply. please let more delve, what type of CC (Temporary or permanent) we can initiate if we proposed to manufacture the new product as an optimization study,
Hi sir thanks for information, I'm A chemist in manufacturing department in API pharmaceutical industry......is there any courses that are use full to me for better knowledge in manufacturing
hello sir what was the flow of change control like after technology transfer documents or R&D (DDR) are completed and handover to the site. what type of batch manufacturing we can start like scale up, optimization, pre-exhibit, trial and what type of change control we have to initiate to proceeding with QMS system like if we take a optimization batch based on DDR then which category of change control (i.e., Temporary or permanent) we have initiate. and after outcome of the study when we start the exhibit or submission batches again which type of change control we need to initiate either temporary or permanent and when it will be closed. please reply soon. thanks.
Change control should be initiated before the Technology transfer is started. As per the change control the TT meetings should be arranged. Hope this will clear your doubt.
@@hitendrakumarshah3718 thanks for your reply. please let more delve, what type of CC (Temporary or permanent) we can initiate if we proposed to manufacture the new product as an optimization study,
Hi sir thanks for information, I'm A chemist in manufacturing department in API pharmaceutical industry......is there any courses that are use full to me for better knowledge in manufacturing
You can connect with me. I will guide you