1.0 PURPOSE:
2.0 SCOPE:
This procedure for reworking or reprocessing of pharmaceutical product is applicable at Pharmaceutical Manufacturing Facility of (Company name).
3.0 DEFINITIONS:
3.1 Reprocessing:
Subjecting all or part of a batch or lot of an in process drug, bulk process intermediate or bulk product of a single batch/lot to previous step in a validated manufacturing process due to failure to meet predetermined specifications.
3.2 Reworking:
4.0 RESPONSIBILITY:
4.1 Production supervisor is responsible for preparation of the protocol and execution of the repackaging activity.
4.2 Head-Production or designee is responsible to ensure that the activity is performed as per the procedure and deviation/incident if any are recorded, informed and authorized from QA.
4.3 Quality Control is responsible to analyze the drug product as per specification.
4.4 Supply Chain & Marketing team are responsible for writing request for repackaging activity.
4.5 Regulatory department is responsible for approval of repackaging activity.
4.6 Head-Quality Assurance or designee is responsible for approval of the repackaging activity.
5.0 PROCEDURE:
5.1 Reworking/reprocessing is not allowed during the batch manufacturing process.
5.2 Repackaging can be done in any of the following conditions only if the quality of final product is not affected.
5.2.1 Return goods from Depot due to change in labeling requirements as mandate by regulatory agencies.
5.2.2 Change in plan from one pack/ market to another pack/market.
5.3 Any repackaging activity has to be approved by Head QA on case to case basis, considering nature of the product, extent of repackaging and the supporting data to ensure that quality, safety, purity, strength and efficacy of the product are maintained.
5.4 Repackaging activities shall be performed on a written request from supply chain and marketing head/designee of existing and new market, if these are different. This request shall be forwarded to Head-QA and plant head for their decision.
5.5 Depending upon the nature of repackaging, a protocol shall be prepared by production and QA. This protocol shall be approved by Regulatory department and final authorization shall be taken from Head-QA.
5.6 This protocol shall be attached in the new batch packing record and shall be adhered during entire repackaging procedure.
5.7 Expiry date of repackaged batch shall be maintained the same as of original batch and shall not be changed.
5.8 Repacking activities can not be performed twice on one batch.
5.9 Repackaged batch shall be released only after complete testing by QC and shall be subjected for stability study as per protocol.
6.0 ABBREVIATIONS:
6.1 QC :Quality Control
6.2 QA :Quality Assurance
7.0 REFERENCES:
8.0 LIST OF ANNEXURES:
Also read: Procedure For Re-Packing
Also read: SOP for Manual Defoiling of Blisters and Bottles