SOP FOR HANDLING OF REPROCESSING AND REWORKING
OBJECTIVE: To describe a procedure for reworking and reprocessing of the batch.
SCOPE: This SOP is applicable for reworking and reprocessing of the batch.
RESPONSIBILITY: Production Operator & Supervisor: Responsible for compliance the reprocessing of the batch with proper documentation.
ACCOUNTABILITY: Head QA is accountable for the implementation and compliance of this SOP.
DEFINITION & ABBREVIATION:
DEFINITION: Reprocessing & Reworking: Re-working is the activity or action done additionally or repeated by adding of additional material any step during packing of the product, taken in case if product does not meet to its pre-defined specifications or acceptance criteria.
PROCEDURE:
The need for rework and reprocessing arise with:
Repacking and relabeling activity shall be taken up in case of special consideration, for example:
- Misprint
- Illegible Overprint
- Mono carton damaged
Glass Bottle, Respules & Plastic Bottle which rejected during labelling like, misprint, illegible overprinting and bottle rejected through visual checker by manually, delabelled such rejected Glass Bottle, Respules & Plastic Bottle in the same primary packing area.
Glass Bottle, Respules & Plastic Bottle mono carton which rejected during packing like, mono carton damaged and packed bottle rejected through visual checker by manually, damaged carton bottles such rejected Glass Bottle, Respules & Plastic Bottle in the same primary packing area.
Production shall initiate repacking & Relabeling requisition to QA as per Annexure-I
Check the quantity (to be repacked) physically and mentioned in the BPR.
Send the requisition to Warehouse for issuance of secondary packaging material (duly signed by QA)
Start the repacking & Relabeling record shall be recorded in BPR.
Then reconcile the packaging material and destruct the rejected/damaged material on a destruction note
QA shall review the reconciliation and shall perform quality impact/regulatory impact, and shall approve the same.
QA in charge shall issue the packing part of the BPR to production.
The repacking activity shall be done after line clearance, and the IPQA officer shall monitor the activity
Carry out reworking / reprocessing under the supervision of QA officer.
Transfer the reworked / reprocessed batch to the warehouse after getting approval from Head – QA and Plant Head.
Repacking & Relabeling Requisition Form Annexure – I
DISTRIBUTION
The SOP shall be distributed to respective department by QA. The QA department shall
Authorize for the distribution of SOP and shall sign for “Issued by: “Follow the distribution of SOP as per following:
Master Copy – QA Department
Control Copy – User Department (Production, IPQA)
Display Copy – Production
The Revised SOP shall be distributed only after retrieval of superseded SOP.