SOP on Batch Numbering procedure for Optimization /Exhibit Batches of Drug Products and Intermediates
Objective : To lay down a procedure on the batch numbering system for optimization/exhibit batches of drug products and intermediates.
Scope : This standard operating procedure is applicable for assigning the batch number to optimization/exhibit batches and intermediate products to be manufactured.
Responsibility :
Officer/Executive-Quality Assurance department shall be responsible for assigning the batch number as per this SOP.
Head-Quality Assurance/Designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
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.)
Intermediate products : These are not final products, but manufactured in manufacturing area from raw materials and after manufacturing returned back to Stores department for storage and issuance. Intermediate products (Intermediate granules, Intermediate tablets, Intermediate vehicles) shall be issued to production from Stores for manufacturing of final products.
Procedure :
Batch Numbering of Optimization/exhibit Batches of Drug Products and Intermediates
Batch number shall consist of nine or ten characters. In case there are different strengths in the same product, then batch number shall consist of ten characters.
The first three characters of a batch number shall be the first three characters of the product name of drug products and intermediates for which it is being issued. One more character can be added, if initial three characters are same that shall be need based.
For Optimization/exhibit batches of Drug Products, the fourth character shall represent the strength of the drug i.e. different strengths of the drug products shall be represented by ‘A’, ‘B’, ‘C’ and so on. In case of single strength, this character shall not be used.
The fifth and sixth characters shall be ‘RD’ which represent the ‘Research and Development department’
The seventh and eight characters shall represent the financial year e.g. 25 for April 2025to March 2026 and 27 for April 2026 to March 2027, etc.
The ninth and tenth characters shall denote the serial number of a batch manufactured in a financial year from April to March. The first batch of a product shall be numbered as 01. The subsequent batches shall be 02, 03, etc. till 99. 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 Nimesulide tablets, manufactured in financial year from April 2025 to March 2026, shall have the batch number as NIMRD2501 (single strength tablets). Similarly, the first batch of Paracetamol tablets, manufactured in financial year from April 2025 to March 2026, shall have the batch number as PARRD2501.
Batch numbering of Intermediate products
Batch number shall start with the product code which is issued to the product.
The next 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 next three characters shall represent the serial number of a batch manufactured in a financial year from April to March. The first batch of a product shall be numbered as 001. The subsequent batches shall be 002, 003, etc till 999. 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.
The assigned batch numbers shall be recorded as per SOP titled ‘Issue, Receipt, Storage and Destruction of Batch Manufacturing Records’.
The batch numbers for exhibit, validation and placebo batches shall be assigned as per SOP ‘Batch Numbering’.