REWORK OF INTERMEDIATE OR API

I.                   PURPOSE

To define the Standard operating procedure for the Rework of Intermediate / API.

II.                SCOPE

This procedure is applicable for all Intermediate / API manufactured at., V.

III.             RESPONSIBILITY

Research Scientist

Head - Quality Assurance

Head - Process Development Lab

            Head - Production

Head - Quality Control

IV.             ACCOUNTABILITY

Head QA

V.                PROCEDURE

1.0       Definition of Rework

Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).

2.0       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.

3.0              Depending upon the nature of quality failure, a discussion is held between QA, Production, QC and PD Lab to determine

3.1              Reasons for failure and investigation there off.

3.2              Whether the batch is to be reworked to improve quality.

3.3              Whether stability studies will be required.

3.4              Whether any specific controls to be excised during rework.

4.0              Based on the out come of this discussion if rework is recommended then following procedure is adopted.

4.1             Based on the area of non-compliance, Plant manager initiates reworking of the failing material/batch under advice from Process Development Lab.

4.2             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.

4.3             Production Department, Process Development and QA discuss the process of reworking suggested by PD Lab, Quality of the reworked batch and stability of the Product based on their study.

4.4             A CPCR / BPCR shall be prepared by production on the basis of R&D / PD Lab recommendation. The respective authority shall approve Cycle Production and Control Record (CPCR) & Batch Production and Control Record (BPCR). Approved CPCR / BPCR shall be issued by QA as per the respective SOP.

4.5             After the batch is reworked, the batch is analyzed for its compliance with specifications.

4.6             A final test report is issued to production from QC after compliance of product with specification. 

4.7             Batch number is assigned as per Batch numbering SOP.

4.8             Adequate documents are prepared to describe the reason, steps taken, and result. These documents become the part of CPCR / BPCR.

4.9             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 the normal production batches.

4.10         Reworked material cannot be dispatched to the Regulated Market.

VI.       REVISION SUMMARY

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