SOP For reprocessing and reworking is described in this post which you can follow in the section of the Quality Assurance Department.
OBJECTIVE
To lay down the procedure for reprocessing and reworking.
SCOPE
This procedure is applicable to reprocessing and reworking of tablets.
RESPONSIBILITY
Production
- To obtain authorization for reprocessing as per defined procedure.
- To proceed for reprocessing as per defined procedure.
- To investigate the reasons for reprocessing.
Quality Assurance
- To ensure reprocessing is done as per defined procedure.
- To ensure proper authorization of deviation form before commencing reprocessing operation.
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
- Reprocessing of batch could occur at any stage of the process from receiving raw material to release for marketing following the complaint.
- 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.
- An investigation report of the same has to be prepared which has to be duly signed by the production officer, QA officer, Manager Production and Manager Quality assurance and Manager Quality Control.
- Once corrective action is determined the batch has to be taken for reprocessing and a deviation has to be raised by production in duplicate.
- The production and QA officer fills the deviation form and details the product, batch no. the standard process followed and deviated process followed and write justification.
- Once all the details are filled up, the form has to be signed by the Manager Production and Manager Quality Assurance along with his remarks.
- The original copy of the completed deviation form is handed over to QA and the respective department retains a duplicate copy.
- Once this process is completed the reprocessing process has to be started as mentioned in the deviation form & investigation report.
- If any material has to be procured from Ware House for reprocessing. Then a requisition has to be generated signed by production & QA.
- After receipt of a requisition by Ware House, MRF is generated which is again signed by production and authorized by QA.
- After receipt of materials, the reprocessing process is started and all data of the process done are recorded along with their timings.
- The data recorded have to be attached in the respective BMR
- 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.
- Manufacturing date on the BMR will be given of the reprocessing month and the expiry shall remain same as shown in the old BMR.