SOP on Batch Numbering System
SOP on Batch Numbering System
1.0 Purpose: This SOP describes the guidelines for allotting an identification system to each batch of the products manufactured at ABC Pharmaceuticals Limited. A batch number (or lot number) is a distinctive combinations of numbers and/or letters which specifically identifies a batch on the labels, production records & certificate of analysis. Complete history of a batch can be traced with this batch number as it is unique.
2.0 Scope: This SOP applies to all the batches of all the products.
3.0 Responsibility: Quality Control Chemist/Production Chemist to ensure that the procedure is followed.
4.0 Materials and Equipment: None.
5.0 Procedure: In a pharmaceutical manufacturing operations, there is a need to produce innumerable number of products. Identification of the drug batches becomes necessary otherwise there may be a difficulty in identifying & tracing their history. Each scheduled manufactured batch is given a sequential number. Batches are manufactured in different departments i.e. capsules, dry syrups, oral liquids & tablets. The batch coding of the finished products will be as follows –
5.1.0 The batch number will have seven or eight digits. The first two or three digits (i.e. alphabets) will represent the company i.e. Arbro & Product Category.
Batch numbers in numerals follow the following prefixes –
For-
Beta Lactam Capsules- ACB
Non-Beta Lactam Capsules – AC
Beta Lactam Dry Syrups- ADB
Non-Beta Lactam Dry Syrups – AD
Tablets (Beta Lactam, Non-Beta Lactam) – AT
Syrups- AS
Suspensions – AU
5.2.0 The batch number will have 5 numerical digits –
5.2.1 The first two numerical digits will represent the year of manufacture i.e. 23 for batch manufactured in year 2023.
5.2.2 The last three numerical digits will represent the running serial number of the batch starting with “ 001”.