SOP Title: Batch coding system

SOP Title: Batch coding system

1. Objective:

To define batch coding system for every batch of products manufactured at the site

2. Scope:

This procedure is applicable to all bulk and finished products manufactured at the site for following dosage forms:

2.1  Tablets

2.2  Capsules

2.3  Liquids

2.4 Creams and ointments

3. Responsibility:

Head QA	:	Overall responsibility for all product identification, batch coding and traceability in the manufacturing site as per procedure
Head Production	:	To ensure that all the products manufactured at the site are identified with their unique batch code as per this procedure

4. Accountability:

Head QA department

5. Procedure:

• Definition:

Batch Code: It is unique code given to identify each batch of the different product manufactured in the site as per this procedure.

Product Code: It is unique code given to each product manufactured in the site for identification and traceability as per this procedure.

 

• Procedure

5.2.1	Procedure of batch coding: Batches for each individual product shall be coded to clarify the following details: Dosage Forms Product identity code Year of manufacturing Serial no. of the batch. These categories are further elaborated and placed in a batch code no. as follows:
5.2.2	Dosage form:
5.2.2.1	The dosage form abbreviation of a product is the first alphabet taken from its dosage form and placed in first place in the batch Code No. / batch No. The following abbreviations shall be used for the different dosage form; T – Stands for the tablets C – Stands for the Capsules L – Stands for the Liquids O– Stands for Creams & ointments
5.2.3	Product identity code:
5.2.3.1	The product identity code shall be placed next to the dosage form abbreviation. It starts with two alphabets AA for first product of the a particular dosage form identified and reaches to AZ for others, further it starts with BA for twenty seventh product identified and so on for all products till ZZ.
5.2.4	Year of manufacturing:
5.2.4.1	The year of manufacture is taken as the numerical number from the last two digit of the current year such as for year 2024, the digit will be 24. The year of manufacture is placed next to the product identity code.
5.2.5	Serial number of batch:
5.2.5.1	The batch serial number is the numerical number between 001 to 999. The batch serial number is placed next to the year and consists of last 3 numerical numbers of any batch numbers. The serial number starts with 001 at the start of each year.
5.2.6	Example for a batch code number of different dosage forms
5.2.6.1	A typical batch code no. of first batch manufactured in year 2024 of different dosage forms  shall be assigned as following: Dosage form Product Code Batch code Batch code/batch number Tablets TAA 24001 TAA24001 Capsules CAA 24001 CAA24001 Liquids LAA 24001 LAA24001 Creams & Ointment OAA 24001 OAA24001

6. Abbreviation:

 

Abbreviation	Expansion
QA	Quality Assurance
QAD	Quality Assurance Department
QAP	Quality Assurance Procedure
No.	Number

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.