Standard Operating Procedure (SOP) for handling and destruction of Non-Recoverable Recovery generated during the processing of pharmaceutical drug products.
Handling and Destruction of non-recoverable Recovery
- The purpose of this SOP to lay down the procedure for handling and destruction of non-recoverable Recovery.
- This SOP is applicable for followings,
- Handling and destruction of non-recoverable recovery generated during processing, compression, capsulation, coating of tablets, and packing.
- Transfer of non-recoverable recovery to washing area / ETP.
4.0 RESPONSIBILITY – NON-RECOVERABLERECOVERY:
- The production officer shall be responsible to check and collect the recovery.
- Officer – Production shall be responsible to make entry in BMR or BPR.
- The production officer shall be responsible for the destruction of recovery as per the defined procedure.
- QA shall be responsible to ensure that proper entry is done in BMR
- QA shall be responsible to ensure the proper destruction of recovery.
- SOP: Standard Operating Procedure
- Cleaning: The removal of the residual product or extraneous matter including microbial contamination from the facility surfaces and/or equipment to an acceptable level and maintaining the condition of the facility or equipment such that it can be used safely for subsequent use.
6.0 PROCEDURE – HANDLING OF NON-RECOVERABLE RECOVERY:
- Collect all the spillage powder / NRR pellets/leftover materials / NRR tablets during operation in a polybag and label as Non-Recoverable Recovery.
- The concerned officer shall inform the IPQA officer for the destruction of NRR as mentioned above and make necessary entry in BMR/BPR if required.
- Transfer the above Non-recovery to the washing area and add in a dedicated container (Container filled with water stored in the washing area for transferring NRR to ETP for disposal).
- Collect the IPQC tablets and add in containers filled with water in the IPQC area and transfer the container to the washing area and in the dedicated container at the end of the shift or as when required.
- Collect excess paste /non-used paste /coating solution in a container and transfer the same to ETP for the destruction.
- Do not drain recovery in the drain.
- Quality Assurance
- ANNEXURES: NA