SOP for Batch Numbering System

PURPOSE

To ensure that each batch of the intermediate, bulk, or finished product is identified with a specific number.

SCOPE

All products are produced by PharmaInfo Ltd.

DEFINITION

Batch:

A defined quantity of starting materials, packaging materials, or products processed in a single process or series of processes so that it could be expected to be homogeneous. It may sometimes be necessary to divide a batch into several sub-batches, which are later brought together to form a final homogeneous batch.

Batch Number:

A distinctive combination of numbers and/or letters that specifically identifies a batch on the labels, commercial cartons, master cartons, records, the certificate of analysis, etc.

Batch Numbering System:

Standard Operating Procedure describing the details of the batch number.

Batch Records:

All documents associated with the manufacture of a batch of the intermediate, bulk or finished product. They provide a history of each batch of products and of all circumstances pertinent to the quality of the final product.

RESPONSIBILITY

Routine responsibility for ensuring that this Procedure is implemented as when necessary rests with the Production Officers and the Production Manager.

The In-Charge, Quality Assurance Division is responsible for SOP compliance.

PROCEDURE

Production Batch Numbering

• It comprises seven digits and includes 07 numerals.

XX/YY/ZZZ

XX: manufacturing Year last two digit

YY: number of Months in Production two-digit

ZZZ: serial number of Batch Production in three-digit

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• An example: Batch number is 2205001 which means 22 the manufacturing Year last two-digit Product is XX 05 stands for the number of months in Production two digit is YY (such as May stands for 05) and 001 denotes a serial number of Batch Production three-digit ZZZ (The Batch number will continue for every different product).

The procedure of Packaging Blister Strip Numbering

• It comprises eight-digit it including 01 letters and 07 numerals.

ZZZ/E/YY/XX

ZZZ: serial number of Batch Production in three-digit

E: Expire date

YY: number of Months in Expire two digit

XX: Expire Year last two digit

• An example: the Blister Strip number is 001E0522 which means the 001 denotes a serial number of Batch Production in three-digit ZZZ (The Batch number will continue for every different product) and E stands for Expire date and 05 stands for the number of Months in Expire two digit YY (such as May stands for 05) and 22 is stands for Expire Year last two digits of Product is XX.
• Record the batch number issued in a Log Book titled Batch Number Log Book, mentioning the date of allocation, product name, strength, dosage form, batch size, and formulation order number.
• Ensure that the batch number issued for a particular batch of a product is used in all relevant documents of the product, label, commercial cartons, master cartons label, etc.
• Identify the product in all processing steps by the same batch number.

ANNEXURE

Nil

REVISION HISTORY

Nil

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