OBJECTIVE:

• To establish a uniform and controlled procedure for assigning batch numbers, manufacturing dates, and expiry dates to all batches manufactured at the facility.
•  To define the presentation format and criteria for printing or engraving these details on all relevant packing materials in compliance with EU-GMP documentation requirements.

 SCOPE:

• This SOP is applicable to all products manufactured, packed, and released at the company’s in-house manufacturing locations.
• It covers all dosage forms and all associated packing materials (primary, secondary, and tertiary).

RESPONSIBILITIES:

Designee Quality Assurance (QA):

• Shall be responsible for assigning batch numbers as per this SOP.
• Shall issue the BMR/BPR with product details, batch number, Mfg. Date, and Exp. Date.
• Shall maintain the Batch Number Issuance Log.
• Shall ensure system integrity, periodic review, and amendment of Annexure I when a new manufacturing location code is introduced.

Production Department:

• Shall request batch number issuance before initiation of manufacturing.
• Shall ensure that the assigned batch number appears correctly on all in-process and finished product documents.

Head – QA:

• Shall review and approve this SOP and ensure overall compliance.

DEFINATIONS:

• Batch: A defined quantity of material or product processed in a single process or series of processes so that it is expected to be homogeneous.
•  Batch Number: A unique alphanumeric identifier assigned to each batch, ensuring traceability throughout manufacturing and distribution.
•  Manufacturing Date (Mfg. Date): The date on which the batch manufacturing process is initiated.
•  Expiry Date (Exp. Date): The date until which the product is expected to remain within the approved specification when stored under defined conditions.

PROCEDURE:

Batch Numbering System:

•  Each Batch Number shall follow the pattern: YYMMNNN, where:
  • • • YY = Last two digits of the manufacturing year
      • MM = Month of manufacturing
      • NNN = Sequential batch number starting from 001
      • Example: 2510001 (First batch of October 2025)
•  All product shall have common batch numbering sequence.
• The numbering shall restart from 001 at the beginning of each calendar month.

Cancellation of Unused Batch Numbers:

• If a batch number has been issued but manufacturing is not initiated, QA shall cancel the number in both the Batch Number Register and the electronic system.
• The cancellation entry shall bear remarks and QA signature with date.

Printing and Embossing on Packing Materials:

Blister Pack:

• Batch Number, Mfg. Date, and Exp. Date shall be engraved or overprinted as:
• No.: YYMMNNN E 10/25

Carton / Label:

• Each Secondary packaging component shall bear overprinted details in the following standard format:
  • • Batch No.: YYMMNNN
    • Date: MMM. YY
    • Date: MMM. YY
    • Any deviation or change from the approved format shall handle through Deviation.

Shipper:

• Each Shipper Label shall bear overprinted details in the following standard format:
  • • • Product Name
      • Batch No.: YYMMNNN
      • Date: MMM. YY
      • Date: MMM. YY
      • Shipper No.
      • Shipper Gross Weight
      • Quantity
      • Storage Condition
      • Manufactured By
      • Any deviation or change from the approved format shall handle through Deviation.

Record Control:

• QA shall maintain a Batch Number Issuance Log.
• The log shall be retained for five years or not less than one year after batch expiry whichever is longer.
• Entries shall be made in permanent ink or controlled electronic format.

Change Control and Revision:

• Any permanent modification in numbering logic, and format shall be initiated through a formal change control.
• All changes shall be reviewed and approved by QA prior to implementation.

Training:

• All relevant QA and Production personnel shall be trained on this SOP before implementation.
• Training records shall be maintained in the training file.

REFERENCE:

• EU-GMP Part I – Chapter 4: Documentation.
• EU-GMP Part I – Chapter 5: Production (Clause 5.12 – Identification).
• Annex 15 – Qualification and Validation (Batch traceability).

RECORDS:

 REVISION HISTORY: