1.0 PURPOSE
To lay down a procedure for Rework of Intermediate / API.
2.0 SCOPE
2.1 This procedure is applicable in Production Department.
3.0 RESPONSIBILITY
3.1 Plant Manager
4.0 ACCOUNTABILITY
4.1 Manager – QA & RA
5.0 PROCEDURE
5.1 This SOP describes guidelines to be followed for production batches that require rework.
5.2 Quality improvement of a batch undertaken to ensure product compliance as per laid down standards by establishing a processing technique in R&D or P.D.Lab, which could be unique for each type of non-conformance.
5.3 Depending upon the nature of quality failure, a joint discussion is held between Production, QC and PD Lab to determine
5.3.1 Reasons for failure and investigation there off.
5.3.2 Whether the batch is to be reprocessed or reworked to improve quality.
5.3.3 Whether stability studies will be required.
5.3.4 Whether any specific controls to be excised during rework.
5.4 Based on the out come of this discussion if rework is recommended then following procedure is adopted.
5.5 On the occasions where rework is necessary, procedure outlined below is followed:
5.5.1 Based on area of non-compliance, plant manager initiates reworking of the failing material/batch under advice from Process Development Laboratory.
5.5.2 Based on the nature of failure R&D/PD Lab conducts suitable experimentation and then recommends a specific method for Quality Improvement, if suitable Rework method is already available the same may be recommended.
5.5.3 Production Department, Process Development Group and QA discuss the process of reworking suggested by PD Lab, Quality of the reworked batch and stability of Product based on their study. PD Lab also suggests about any change in method of analysis, if required.
5.5.4 A BPCR shall be prepared by production on the basis of R&D / PD Lab recommendation. Batch Production and Control Record (BPCR) shall be approved by the respective authority. Approved BPCR shall be issued by QA as per the respective SOP.
5.5.5 After the batch is reworked, the batch is analysed for its compliance’s with specifications.
5.5.6 A final test report is issued to production from QC after compliance of product with specification.
5.5.7 Batch number is assigned in continuation of same series.
5.5.8 Adequate documents are prepared to describe the reason, steps taken and final result. These documents becomes the part of batch production record.
5.5.9 The stability studies of reworked will be undertaken if the method used in unique and has not been studied for stability earlier. The reworked batches may be released for commercial purposes, if the quality of such batches is similar to normal production batches.
END OF DOCUMENT
Rework, intermediate api,
