Procedure For Re-Packing

1.0 PURPOSE:

To define the procedure for Re-packing of tablets and Capsules.

2.0 SCOPE:

Procedure for Re-Packing is applicable for all products packed in Production Department of at (Company name).

3.0 DEFINITION:

Not applicable.

4.0 RESPONSIBILITY:

Execution: Operator; Checking: Production Staff; Accountability: Production Head

5.0 FREQUENCY:

As and when required.

6.0 PROCEDURE:

6.1 For Re-packing of a product follow the procedure mentioned in the respective Incident. 
6.2 Take approval from Quality Assurance department for re packing.
6.3 Production personnel shall raise the indent for the required packing material and shall request to QA for issuance of particular BPR or re-packing record.
6.4 After issuance the particular BPR, use the respective Batch Processing Record to capture the packing details.
6.5 Receive the required packaging BPR for the product from QA.
6.6 Prior to starting the Re-packing operation identify the packaging materials to be procured from the warehouse.
6.7 Get the required packaging materials dispensed from the warehouse as per the proper packing material requisition.
6.8 If any of the activities required to be performed is not covered in the scope of the respective Packaging BPR, that activity shall be documented in a suitable Annexure.
6.9 Transfer the packed goods from finished goods store to secondary packing area.
6.10 All the activity of re packing shall be done in presence of IPQA.
6.11 Production personnel shall take the line clearance from IPQA prior to re-opening activity in secondary packing area.
6.12 Ensure that no material of previous product/ batch is present in secondary packing area and then start the re-opening activity.
6.13 Collect and segregated the re-opened packaging material from secondary packing area and destroy impacted packing material in such a way that over-coding details get de-faced. Carryout the destroyed packing material reconciliation and recorded in the BPR
6.14 Transfer the de-faced material to scrap- yard duly checked by production and verified by IPQA.
6.15 Ensure that before start of Re-packing, the Defaced packing materials are to be destroyed.
6.16 Ensure that area should be free from Defaced packing materials which are to be replaced with newly dispensed re-packing materials.
6.17 Take the line clearance for Re-packing.
6.18 Follow the packing procedure as per the respective BPR.
6.19 After completion of re-packing, Carryout the yield reconciliation of the re-packaging.

7.0 REFERENCE:

Nil.

8.0 ABBREVIATIONS:

BPR: Batch Processing Record 
IPQA: In Process Quality Assurance
QA: Quality Assurance

9.0 ENCLOSURES:

Nil.

2 thoughts on “Procedure For Re-Packing”

  1. Pingback: Procedure for receipt and issuance of packing materials for machine trial -

  2. Pingback: SOP for reworking or reprocessing of pharmaceutical product -

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top