Hello Sir,
I have this Question regarding Line Clearance and In-Process Control (Checks) and I was Hoping that if you could answer me with reference to any GMP related guidelines. So here is my Question:
Q: If a batch has objection and QA doesn’t allow it to process but for some reason production department starts it, Is it Okay to do In-process controls (checks) and document them on BMR? even though Line Clearance is not signed by QA and they have objection? and to further add it. Is it okay to Market such batch that wasn’t approved by QA?
The answer is very simple. The batch can not be sent to the market for sale unless it is released by QA. Therefore, there is no question of sending the batch to the market for sale.
Secondly, without QA Line clearance (as per internal SOP), further processing of the batch should not be carried out. However, QA should be able to provide appropriate justification for not certifying Line clearance and not allowing to process further. There has to be justified reason based on either Technical / Scientific / Regulatory aspects.
If this issue could not be resolved at the plant level then there should be an intervention of senior management.
Please refer responsibilities of the Quality Unit (QA) in any GMP guidelines.
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