Pharmaceutical Guidelines

Quality Assurance (QA) in the Pharmaceutical industry, is very essential for ensuring that Pharmaceutical Products are manufactured to a safe and consistent standard, and references with the guidelines, WHO, GMP are the main principles for pharmaceutical products.

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Wednesday 2 December 2020

Reconciliation Of Printed Packing Material SOP

 

1.0               OBJECTIVE:

To describe the procedure for reconciliation of printed packaging materials to avoid misuse and mix ups.

2.0              SCOPE:

This SOP is applicable to printed packaging material procured at --------------------------------

3.0              RESPONSIBILITY:

Production Officer/designee & HOD responsibility for follow this SOP, and IPQA Officer & Q.A. Head responsible for complies this SOP.

4.0              ACCOUNTABILITY:

The Accountability lies upon implementation & complies production HOD & Q.A. Head.

5.0              PROCEDURE:

5.1              The printed packaging material can be divided in 3 parts:-

5.1.1        Labels, cartons, Shippers.

5.1.2        Aluminum Foils.

5.1.3        Inserts or leaflet or literature, ROPP Caps, Tubes.

5.2              Procedure for Labels, cartons, Shippers:

5.2.1        After completion of packing of particular batch, determine the quantity of labels, cartons and shippers (Packing material) consumed taking into account the packed quantity for FGTN and transfer to FG store. There after reconciliation of rejections of packing material on the packing processing, sample drawn by QA department for In-process testing, for control sample and stability sample and quantity left unused in hand.

5.2.2        And Compare the consumed quantity with the requisition quantity.

5.2.3        Determine whether the unused quantity that is left in hand that can be returned to Warehouse with Excess Material Requirement / Return Memo or not i.e. the overprinted labels, cartons and shippers cannot be used for next batch and hence are to be destroyed as per destruction SOP. The labels, cartons and shippers that are not overprinted shall be return to Warehouse.

5.3              Procedure for Aluminum Foil:

5.3.1        Reconcile the foil by comparing the quantity issued and consumed in batch packing

5.3.2        If any foil is left then overprinted part of the foil shall be removed and destroyed.

5.3.3        The remaining foil shall be weighed and return to Warehouse with Excess Material Requirement / Return Memo

5.4              Procedure for Inserts of leaflet or literature, ROPP Caps:

5.4.1        As there shall be no overprinting on leaflet or ROPP caps, they shall be counted or an approximation shall be made and returned to Warehouse with Excess Material Requirement / Return Memo

5.4.2        Acceptance criteria: Reconciliation of issued quantity should be match with used, rejected, destroyed and returned qty.

5.4.3        Frequency: After completion of packing of every batch.

 

6.0              LIST OF ANNEXURE AND FORMAT:

Sr. No.

Title of Format

Format No.

01

NA

NA

 

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

8.0              REVISION HISTORY:   

Sr. No.

Date

Reason for Revision

Revision No

1.          

31/10/2018

New SOP

R0

2.          

31/10/2020

Schedule Revision

R1

 

9.0              ABBREVIATIONS:

Sr. No

Abbreviations

Details

  1.  

SOP

Standard operating procedure

  1.  

NA

Not applicable

  1.  

QA

Quality assurance

  1.  

ROPP

Round of pilfer proof

  1.  

HOD

Head Of Department

  1.  

FGTN

Finish Good Transfer Notes

  1.  

FG Store

Finish Good Store

 

 

 

 

 

 

 

 

 

 

 

 

END OF DOCUMENT

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