SOP on Batch Numbering
Objective : To lay down a procedure of the batch numbering system for the products.
Scope : This standard operating procedure is applicable for assigning batch number to all the different formulations to be manufactured at different locations.
Responsibility : Officer, Quality Assurance department shall be responsible for assigning of the batch number
Head, Quality Assurance shall be responsible for compliance of this SOP.
Batch Number : A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words ‘Batch No.’ (as per Rule Number 96 (v), Drugs and cosmetics acts, 1945.)
Procedure : A batch number shall be numbered by seven characters.
The first three characters of a batch number shall be the product code for which it is being issued.
The fourth character shall represent the last digit of starting year of financial year e.g. 5 for April 2025 to March 2026 and 6 for April 2026 to March 2027, etc.
The fifth, sixth and seventh characters shall be location specific and denote the serial number of a batch manufactured in a financial year from April to March.
For Goa the serial number shall start from 001 onwards. For example: the first batch of a product shall be numbered as 001. The subsequent batches shall be 002, 003, etc. till 499.
For Baddi serial number shall start from 501 onwards. For example: the first batch of a product shall be numbered as 501. The subsequent batches shall be 502, 503, etc. till 599. After 99 batches of same product the serial number shall be 600 onwards i.e. 599, 600, 601, 602, etc.
The batch series of a product shall change with change in financial year i.e. at the beginning of financial year a new series shall start, i. e. the first batch of Paracetamol with product code 010, manufactured in financial year from April 2025 to March 2026, at Goa shall have the batch number as 0105001. Similarly, the first batch of Paracetamol with product code 010, manufactured in financial year from April 2025 to March 2026, at Baddi shall have the batch number as 0106501 and the one hundred fifth batch of Paracetamol with product code 010, manufactured in financial year from April 2025 to March 2026, at Baddi shall have the batch number as 0106605 .
For all locations except Baddi the assigned number shall be recorded in the batch issuance register.
If the batch is to be repacked or redressed, than an alphabet ‘A’ in capital letters shall be suffixed with the original batch number to give traceability to the repacked or redressed lot or batch number e.g. if the first batch of Paracetamol having batch number 03105001 is redressed then batch number shall be 0105001A.