Recently, the site I work at has revised an SOP to state that if we receive an OOS for in-process testing during compression it is not a deviation if we segregate the material and still meet yield. Is updating the SOP enough to say that there is no deviation there or would the presence of the OOS (even though it was segregated and covered by the SOP) dictate that it is a deviation regardless?
The short answer is yes, there is no regulatory expectation that you have to issue a deviation for every OOS you encounter as part of in-process controls; since this is part of your SOPs that make sure you meet cGMP; this is not tha case for finished product testing, since by that time, batch is expected to always meet specifications, if not, there is evidence that batch is not meeting critical quality attrbutes (CQA).
However, you have to be very careful in how your quality management system (QMS) handles these events. The keyword you mentioned is OOS in a product, not just an our of control limits, this means that this event falls under the scope of 3 elements of the QMS:
- Process deviation management
- Handling of non-conforming product (NCP)
- Quality Risk Management (QRM)
In short, your QMS does not need to dictate the creation of a process deviation for this event if your SOP complies with these 3 elements of the QMS. some things to consider in your SOP to be effective:
- Understanding process variation. Does this OOS trigger an event or deviation, due to its adverse trend on CPV (continous process verification)?
- Did you stopped production until fixed?
- What is done with the product that was manufactured so far until the presence of this OOS? Did you segregated all product since last in-process result?
- What measures must be taken to make sure that no NCP gets released?
- Does this OOS event trigger some kind of investigation or does ir require ioly the adjustments of process parameter? Where Critical Process Parameters (CPP) within validated range?
I hope this helps.
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