Brenda,
You don't say whether your question applies to drugs or devices. I don't know the pharma GMPs well enough to comment, so I will stick to devices.
A partial release of a lot is technically possible, but generally isn't a good practice, for a lot of reasons, not the least of which is dealing with the decision of what to do about it if there is a later failure in release testing for the rest of the bigger production run. However, if you must do it, here are a few things to consider.
- release testing must be done and documented. If the full run has not yet completed release testing (which would be ideal), then you need to establish that appropriately sampled testing has been done on the "sub-lot." This is a lot easier to do if the release testing is 100% testing of all products and at points very hard if it is a statistical sampling plan (because that assumes things about the distribution of the entire lot which may or may not apply to the sub-lot).
- some way of tracking this "sub-lot" within the bigger lot must be established - this should ideally tie into your ERP system
- depending on how your manufacturing procedures are written, you may need to complete a deviation or other documentation establishing why it is ok to vary from the released process
If this is a routine "practice" I would say the best bet would be to proceduralize it - then it is very clear what testing, documentation etc is needed each time it comes up.
g-
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
Original Message:
Sent: 30-Nov-2016 15:42
From: Brenda Miller
Subject: Batch Release
Director of Operations usually create manufacturing orders for a big amount of product and refuse to do a small manufacturing order. In the middle of production if a customer order enter into the system, he request to Quality to do a partial release of the batch. If that possible, and what will be the correct way to document a partial batch release.?
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Brenda Miller
Quality Assurance Manager Combat Medical Systems
Harrisburg, NC
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