Follow
Objective: To provide a guideline for reprocessing.
Scope: This procedure is applicable for reprocessing in tablet department at (Company Name).
Responsibility:
1. Production officer shall be responsible for recording the necessary details & to perform the activity as directed.
2. Head of production /Manager, QA shall be responsible to investigate the cause for reprocessing and suggest corrective action.
3. Manager, R&D shall be responsible to provide necessary method based on the investigation report and preventive measures.
4. Head of QA shall be responsible to review of the problem and investigation report, and approving the same.
Accountability: Head of Quality.
Precautions: No reprocess works will be carried out until it is formally agreed by Head of Quality Assurance.
Procedure:
1. Definition of Reprocessing.
2. The operation which is to be undertaken for all or part of a batch of product of an unacceptable quality from a defined stage of production, so that its quality may be rendered acceptable by one or more additional operations.
3. For reprocessing situations, thorough investigations shall be carried out as per failure investigation procedure (SOP No.: QA010) and reasons for the deviated results shall be find out and recorded. Log register for reprocessing shall be maintained with all the information of the reprocessing product (Annexure-I).
4. Various stages and the reasons for reprocessing are as given under.
5. Compression: Capping, chipping, sticking, weight variation, failure in content uniformity, failure in disintegration time, hardness, friability, dissolution test.
6. Coating: Spotting, mottling, peeling of film, pinholes, failure in disintegration time.
7. Blistering: Failure in leak test.
8. For physical parameters, sufficient number of samples shall be tested for the parameter, which is deviated, so as to support the conclusion drawn for reprocessing.
9. For failure in content uniformity, deviated results shall be verified as per SOP for handling of out of specification results
10. Reworking using extra quantity of actives shall be allowed only if investigations reveal that there is loss of material (spillage) during processing or there had been error (short supply) during dispensing.
11. Investigations shall be carried to demonstrate that quality of finished product is not affected and its specifications are met, after reprocessing/rework.
12. R&D shall workout reprocessing procedure and get approved from QA.
13. Reprocessing shall be carried out as per approved procedure given by R&D.
14. For export reprocessing is not acceptable, however reprocessing shall be done as per approved procedure given by R&D and batch shall be transferred into local /domestic market.
15. Records of all the steps involved during reprocessing shall be adequately maintained.
16. Finished product samples shall be critically tested to ensure that its quality is not affected because of reprocessing.
17. Reprocessed batch shall be kept for long term stability study.
18. All the details of reprocessing shall be included in Batch Production Record (BMR/BPR)
