Topic: I would like to issue one month's stock at a time, and draw off what I require as needed - what GMP concerns will I need to address to allow me to do this?9 July 2014 Last edited: 9 July 2014 At 2:35pm
Rocco Duran Community Member 3 Posts
Re: I would like to issue one month's stock at a time, and draw off what I require as needed - what GMP concerns will I need to address to allow me to do this?11 July 2014 at 11:39am
The primary risk or concerns that need to be addressed by the firm is related to accountability traceability and potentially cross-contamination of these materials, especially items like silica gel materials which may be product contact materials.
Let me address the first issue, that of accountability...it is still important that there be some process at the packing area to reconcile usage on a per batch basis to ensure that these materials are being used as per batch records and product requirements.
Secondly with regards to traceability, there should be some mechanism in the batch record to document the lot numbers of the materials used in the different batches in case there is a quality or recall issue that occurs with these materials and they need to trace the batches they were used in.
Lastly, depending how they are used and whether they are used for different batches of the same product or different product they need to have a process to control potential risk of cross-contamination if used with product contact.
I particularly like the way the plan to issue and control these materials.
Malcolm Ross Community Member 1 Post
Re: I would like to issue one month's stock at a time, and draw off what I require as needed - what GMP concerns will I need to address to allow me to do this?11 July 2014 at 11:47am
I believe that there is no GMP concerns provided that appropriate records and sign offs are put in place and that appropriate SOP's are constructed, trained and followed. The main concern is really one of stock keeping, that is accountability. From the way the question is asked I feel that the questioner is fully aware of the issues because he mentions that the intermediate store will be in locked cages with limited access....this is the big clue to the issue.
In regulatory terms what he has created is an intermediate store under controlled conditions and I see no problems.