1.0 OBJECTIVE
To lay down the procedure for reprocessing and reworking.
2.0 SCOPE
This procedure is applicable to reprocessing and reworking of tablets.
3.1.2. To proceed for reprocessing as per defined procedure.
3.1.3. To investigate the reasons for reprocessing.
3.2.2. To ensure proper authorization of deviation form before commencing reprocessing operation.
5.2. A detailed investigation has to be done by production and quality assurance to determine the reason for reprocessing and also to find out corrective action.
5.3. An investigation report of the same has to be prepared which has to be duly signed by the production officer, QA officer, Department head and authorized by the Unit head and Quality head.
5.4. Once corrective action is determined the batch has to be taken for reprocessing and a deviation has to be raised by production in duplicate.
5.5. The concerned officer fills in the deviation form and details such as product, batch no. the standard process followed and deviated process followed and justification for the same.
5.6. Once all the details are filled up, the form has to be signed by the department head along with his remarks.
5.7. Sr. no. of the deviation form assigned by Quality Assurance department.
5.8. Finally Quality head and Unit head along with their remarks authorize the deviation form.
5.9. The original copy of the completed deviation form is handed over to QA and the respective department retains a copy of the same.
5.10. Once this process is completed the reprocessing process has to be started as mentioned in the deviation form & investigation report.
5.11. If any material has to be procured from Ware House for reprocessing. Then a requisition for the same has to be generated signed by production & QA.
5.12. After receipt of a requisition by Ware House, MRO is generated which is again signed by production and authorized by QA.
5.13. After receipt of materials, the reprocessing process is started and all data of the process done are recorded along with their timings.
5.14. The data recorded have to be attached in the respective BMR
5.15. If the entire batch is to be reprocessed a New Batch Manufacturing Record has to be issued and filled which will be enclosed along with the original Batch Manufacturing Record.
5.16. Manufacturing date on the BMR will be given of the reprocessing month and the expiry shall remain same as shown in the old BMR.
3.0 RESPONSIBILITY
3.1. Production
3.1.1. To obtain authorization for reprocessing as per defined procedure.3.1.2. To proceed for reprocessing as per defined procedure.
3.1.3. To investigate the reasons for reprocessing.
3.2. Quality Assurance
3.2.1. To ensure reprocessing is done as per defined procedure.3.2.2. To ensure proper authorization of deviation form before commencing reprocessing operation.
4.0 ACCOUNTABILITY
4.1 Manager Quality Assurance5.0. PROCEDURE
5.1. Reprocessing of tablets/capsules could occur at any stage of the process right from manufacturing to receiving material back from the market following the complaint.5.2. A detailed investigation has to be done by production and quality assurance to determine the reason for reprocessing and also to find out corrective action.
5.3. An investigation report of the same has to be prepared which has to be duly signed by the production officer, QA officer, Department head and authorized by the Unit head and Quality head.
5.4. Once corrective action is determined the batch has to be taken for reprocessing and a deviation has to be raised by production in duplicate.
5.5. The concerned officer fills in the deviation form and details such as product, batch no. the standard process followed and deviated process followed and justification for the same.
5.6. Once all the details are filled up, the form has to be signed by the department head along with his remarks.
5.7. Sr. no. of the deviation form assigned by Quality Assurance department.
5.8. Finally Quality head and Unit head along with their remarks authorize the deviation form.
5.9. The original copy of the completed deviation form is handed over to QA and the respective department retains a copy of the same.
5.10. Once this process is completed the reprocessing process has to be started as mentioned in the deviation form & investigation report.
5.11. If any material has to be procured from Ware House for reprocessing. Then a requisition for the same has to be generated signed by production & QA.
5.12. After receipt of a requisition by Ware House, MRO is generated which is again signed by production and authorized by QA.
5.13. After receipt of materials, the reprocessing process is started and all data of the process done are recorded along with their timings.
5.14. The data recorded have to be attached in the respective BMR
5.15. If the entire batch is to be reprocessed a New Batch Manufacturing Record has to be issued and filled which will be enclosed along with the original Batch Manufacturing Record.
5.16. Manufacturing date on the BMR will be given of the reprocessing month and the expiry shall remain same as shown in the old BMR.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 BMR: Batch Manufacturing Record
6.3 QA: Quality Assurance
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After QC analysis one parameter found out of spec after blending of PFS. Then it is decided to add additional excipient (already used in the formulation) and perform the blending again. Is this type of practice rework or reprocess? Its confusing. Please clarify.
ReplyDeleteIt is neither rework nor reprocess. It will be processed through deviation.
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