Standard Operating Procedure of Control Of Non-Conforming of Pharmaceuticals Products is describe in this post.
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1. PURPOSE
This SOP describes how to control, treat and dispose-off non-conforming products including Rejected materials.
2. SCOPE
This SOP controls all the steps taken in dealing with non-conforming products including reprocessing, rejected materials, Stability Study Batches and their storage.
3. RESPONSIBILITY
3.1 All Head of Departments are responsible for proper segregation, Identification and treatment of non-conforming products.
3.2 Q.A. Department has to ensure that non-conforming products are suitably identified, properly segregated and treated according to relevant SOPs during storage and production.
3.3 Technical Committee is responsible for the decision regarding the final use of the product.
4. MATERIAL & EQUIPMENT
4.1 Non-conforming product(Products)
5. PROCEDURE
5.1 REPROCESSING
5.1.1 Reprocessing is subjecting all or part of a batch to a previous step due to failure to meet predetermined specifications. Reprocessing should be in exceptional case only.
5.1.2 If a product has out of specs/non-conforming results then Deviation form is raised by QC department.
5.1.3 In case of non-conformance during production process at any stage deviation will be raised by the observer either from production or QA department.
5.1.4 Full Scale Investigation of Out Of Specification (OOS) is carried out by Technical Committee (consisting of Executive Director, Q.A. Manager, Q.C. Manager and Production Manager if required) and recorded on Analytical Investigation report.
5.1.5 If out of specs./non-conforming results are confirmed then final decision about the batch which may be reprocess (if possible) or rejection is decided by Technical Committee.
5.1.6 All reprocessed portions of batches are segregated & clearly marked by a “REPROCESS” sticker.
5.1.7 The batches after reprocessing are subjected to additional Q.C. testing against specifications.
5.1.8 Record of the steps taken & the tests done are attached with Batch Manufacturing Record.
5.1.9 A copy of deviation form is attached with Batch Manufacturing Record.
5.2 REJECTION
5.2.1 Products which have been rejected by the Q.C. and cannot be recovered or reprocessed are rejected products.
5.2.2 Procedure is same as in points 5.1.2 to 5.1.4.
5.2.3 Rejected product is segregated & clearly marked by a sticker “REJECTED” (Red color).
5.2.4 Rejected product is sent for incineration/destruction & appropriate record is maintained.
5.2.5 A copy of deviation is attached with Batch Manufacturing Record.
5.3 STABILITY STUDY BATCHES NON-CONFORMITY
5.3.1 Batch under stability which does not comply with all stability specification is defined as stability study non-conformity.
5.3.2 OOS results at stability study are first investigated & further decision regarding the batch and further batches is decided by Technical Team (comprising of Executive Director, Q.A. Manager, Q.C. Manager and Production Manager if required).
5.3.3 All the QC OOS results are recorded in QC OOS log.
5.3.4 OOS results of stability study of marketed batches are reported on the respective stability study report.
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