Batch Numbering SOP for Finished Products

Learn how to write a standard batch numbering SOP for finished products in the pharmaceutical industry.

1. PURPOSE

To describe a batch numbering system and how to assign a unique batch number for eachpharmaceutical finished product, acquired or produced by this Pharmaceutical.

2. SCOPE

 This procedure is applicable for Batch numbering system of all finished products manufactured in this pharmaceutical.

3. ASSOCIATED DOCUMENT

Approved Annexure of specific product.

4. PRECAUTIONS

Batch number should be unique for each and every batch.

5. RESPONSIBILITIES

Quality Assurance Department is responsible for giving the batch number of product.

6. ACCOUNTABILITY

 Head of the Quality Assurance Department

Read Also: SOP for Annual Product Quality Reviews (APQR)

7. PROCEDURE             

7.1 Here we used seven digit numerical numbers (e.g. MMYYNNN) for the batch number.

7.2 The first two digits (MM) represent the number for month of production. If the month of production is January then it represent as 01, for February 02 and will continue it respectively till December month. Then repeat it again from January month.

7.3 The middle two digits (YY) represent the last two numbers for year of production. If the year of production is 2024 then it represents as 24, for 2025 is 25 and will continue it respectively for every year

7.4 The last three digits (NNN) representing the Batch Serial number of the individual product. This serial number will start from 001 up to 999. After end of 999^th batch of the individual product the batch serial number will again start from 001 up to 999.

7.5 Example of a specific Product Batch No.

If the First batch number of Paracetamol Tablet is 0124001. Then it represents as follow:

01 = Two numbers for month of production.

24 = Two numbers for year of production.

001 = Batch Serial number of Paracetamol Tablet.

8. ABBREVIATIONS

8.1 SOP: Standard Operating Procedure          

8.2 QC: Quality Control

9. APPENDICES

Nil