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Batch Stamp Preparation SOP in Pharma

In pharmaceutical industry Batch Stamp Preparation SOP is used for printing on unit carton, label etc

Batch Stamp Preparation OBJECTIVE

1.1 To lay down the procedure for making batch stamp.

SCOPE

2.1 The scope of this SOP pertains to procedure for making batch stamp.

RESPONSIBILITIES

3.1 It is the responsibility of Production Pharmacist (packing) to ensure that this SOP is followed as it is written.

3.2 It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary.

DEFINITIONS & ABBREVIATIONS

4.1 SOP: Standard Operating Procedure

4.2 BPR: Batch Processing Record

MATERIALS & EQUIPMENTS

NA

PROCEDURES

6.1 Confirm batch number from batch order.

6.2 Confirm manufacturing date from final release report and 1st processing day on BPR.

6.3 Assign the price and expiry date in accordance with the currently prescribed price list.

6.4 Batch stamp for blisters/strip:

6.4.1 Batch stamp for blister and strip packs is in following format.

BATCH # EXP MONTH YEAR

For Example, if Batch number is: 18A001
And Expiry is: January 2020
Then Stamp on Blister and Strip will be as given below:

16A001EXP012020

6.5 Batch stamp for label and cartons:

6.5.1 Batch stamp for label and cartons is in the following format

  B. NO.:      18A001
  Mfg date:  01/01/18
  Exp date:   01/01/20
  MRP.          00.00

 

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