Reconciliation and Destruction of Packing Materials

 In this post Standard Operating Procedure of Reconciliation and Destruction of Packing Materials in pharmaceuticals is describe.

1.0     OBJECTIVE:

To lay down a procedure for reconciliation & destruction of packing materials.

2.0     SCOPE:

This procedure is applicable to reconciliation & destruction of packing materials in the production area.

3.0     RESPONSIBILITY:

Technical associate Production, Officer and Executive, Production Department – for execution. Head Production – shall ensure compliance and implementation.

4.0     DEFINITION(S):

NA

5.0     PROCEDURE:

5.1      Batch wise reconciliation shall be done as per the respective BPR.

5.2      Enter the details in the ‘Reconciliation of Packing Material’ table in the BPR.

5.3      Count the rejected units after completion of packing operation and collect in separate poly bag for destruction.

5.4      Record the rejects in the BPR (Rejects will include all unused, overprinted, loose primary and secondary packing material or rejected due to on-line detection of any defect.)

5.5      Follow the below mentioned procedure for destruction of various packing materials.

5.6     Aluminum Foil, PVC/ PVDC Film:

5.6.1     On completion of the batch, weigh the scrap and trim and record the foil rejections on the respective BPR.

5.6.2     Ensure that foil rejection does not contain any product. Return the unused good quantity of Aluminum foil, PVC/PVDC Film in rolls to stores.

5.6.3     Collect all the rejected printed packing material (Printed aluminum Film, PVC/ PVDC film) and transfer it to scrap area for destruction. Collect the  material in polybag, tie it properly and label as “SCRAP”.

NOTE: Deactivation of Aluminum foil, PVC/PVDC Film, Bottles, cap used in Cephalosporin Block are to 

be deactivated as per SOP before sending it to the scrap yard.

5.7      Labels, Cartons, Leaflets and Catch Covers

5.7.1     In case of cartons/ labels/catch covers rejected during overprinting, destroy the rejection by tearing into pieces and record the quantity in the respective batch record.

5.7.2     On completion of batch count and record quantity of the rejected and unused (Overprinted or blank) materials.

5.7.3     Destroy these materials by tearing into pieces and transfer to scrap area.

5.8     Corrugated boxes

5.8.1     On completion of batch, count and record quantity of corrugated boxes. Deface and tear  these corrugated box and transfer to scrap area.

6.0     ABBREVIATION(S):

BPR : Batch Packing Record PVC : Poly Vinyl Chloride

PVDC : Poly Vinyled-ene Chloride

7.0     REFERENCE(S):

SOP: Destruction of materials.

8.0     ANNEXURE(S):

Nil

9.0     DISTRIBUTION:

9.1     Master copy : Quality Assurance

9.2      Controlled copy( s) : Production department, Quality Assurance, P & A.

9.3      Reference copy (s) : Production department (2 copy)