sop for rework procedure

 

1.0. OBJECTIVE: 

The objective of this SOP is:
1.1 To describe a procedure for Rework of dosage forms which require change of packaging components(s).

2.0. RESPONSIBILITY:
2.1 Initiating Department shall be:
2.1.1 Responsible to fill up the requisition for rework in the form
2.1.2 Responsible seeking recommendations of Head – Plant Operations in the Rework form

2.2 Head – Quality Assurance shall be:
2.2.1 Responsible for review and approval of Rework Request.

3.0. ACCOUNTABILITY:

Head – Quality Assurance

4.0. PROCEDURE:

4.1 Initiating Department (Production / Finished Goods Warehouse etc.) shall fill the Part-A of Rework request form In duplicate for rework of finished goods (Refer Annexure-I) and send the same to Location Head for his approval. The form shall specify nature of rework, reason for rework, corrective actions, if any, to avoid similar situation in future.
4.2 The Location Head shall forward the Rework request with his recommendations in Part-B of Rework request form to Head – Quality Assurance.
4.3 Head – Quality Assurance shall evaluate the feasibility of rework and Approve or Reject the request for Rework with his comments for any additional sampling or testing if required. QA Head will forward the original copy of Approved / Rejected Part C of Rework request to initiating department and the Duplicate copy shall be retained in QA Department.
4.4 The Initiating Department shall forward the Approved Rework request to Finished goods stores or Production wherever the finished goods are kept.
4.5 Initiating Department shall send request to QA Department to send the executed Batch Manufacturing Record to Production and the packaging Order to Warehouse for issuing the material to Production.

4.6 The finished goods if stocked at warehouse shall be sent to Production floor through a return transfer ticket (TT) for Rework with Approved rework request.
4.7 Rework activity shall be carried out as per the nature of Rework mentioned in the Rework request form and same shall be documented in Batch Manufacturing Record in a manner similar to normal packaging activity.
4.8 The original Rework request form and return TT (If applicable shall be filed in the BMR and Reworked material shall be transferred to stores following Finished goods clearance Procedure.
4.9 The separate Batch reconciliation record shall be used for reconciliation of Reworked finished goods.

5.0. REASON FOR REVISION:

This SOP is revised due to revision due date.

6.0. TRAINING:
Trainer — Head – Quality Assurance
Trainee — All departmental heads / Quality Assurance Personnel
Period — One day

7.0. DISTRIBUTION:
Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Head of Department – Warehouse
Certified Copy No. 3 : Head – Plant Operations
Original Copy : Head – QUALITY ASSURANCE

8.0. ANNEXURE:
Annexure – 1 : Format for Rework request.

9.0. REFERENCE:
In-House

 

ANNEXURE – 1
FORMAT FOR REWORK REQUEST FORM