OBJECTIVE:

• The purpose of this Standard Operating Procedure is to establish a uniform, systematic, and traceable method for assigning document numbers, batch records, equipment/Instrument codes, utility numbers, material codes, and related identifiers to all controlled documents generated under the Quality Management System.

 SCOPE:

• This procedure is applicable to all departments of the organization involved in preparing, reviewing, approving, and maintaining master documents, batch documents, protocols, reports, and records.
• It also covers numbering of equipment, utilities, instruments, materials, and accessories used at the manufacturing site.

RESPONSIBILITIES:

Designee Quality Assurance (QA):

• To the number as per user request.
• control and maintain the master list of assigned numbers.

Department Heads:

• To follow assigned numbers as per this SOP and record them in departmental registers / Documents.
• To paste the assigned number on Instruments / Equipment / Accessories / Area

All Users:

• To ensure correct number usage in all documents and records.

DEFINATIONS:

NA

 PROCEDURE:

General Pattern:

• Each number shall consist of a prefix (identifying category) followed by a running serial number.
• The running serial number shall be represented by NNN depending on the category volume.
• Example: RA001 – “RA” stands for Raw Material (API) and “001” is the first material in the sequence.
• Once the number allotted to documents / Instrument / Equipment / Utilities / Accessories / Material, the number shall not be reused.

 Raw and Packing Materials:

• Each Raw Material (API) shall carry a unique identification number using the following pattern: RANNN, where:
• • • RA = Raw Material (Active Pharmaceutical Ingredient) identifier
    • NNN = Running serial number starting from 001
    • Example: RA001

• Each Raw Material (Excipient) shall carry a unique identification number using the following pattern: RENNN, where:
  • RE = Raw Material (Excipient) identifier
  • NNN = Running serial number starting from 001
  • Example: RE001

• Each Coloring Material shall carry a unique identification number using the following pattern: RCNNN, where:
  • RC = Coloring Material identifier
  • NNN = Running serial number starting from 001
  • Example: RC001

• Each Flavoring Material shall carry a unique identification number using the following pattern: RFNNN, where:
  • RF = Flavoring Material identifier
  • NNN = Running serial number starting from 001
  • Example: RF001

• Each Solvent shall carry a unique identification number using the following pattern: RSNNN, where:
  • RS = Solvent identifier
  • NNN = Running serial number starting from 001
  • Example: RS001

• Each Aluminum Foil shall carry a unique identification number using the following pattern: ALNNN, where:
  • AL = Aluminum foil identifier
  • NNN = Running serial number starting from 001
  • Example: AL001

• Each PVC Foil shall carry a unique identification number using the following pattern: PVNNN, where:
  • PV = PVC foil identifier
  • NNN = Running serial number starting from 001
  • Example: PV001

• Each Product Leaflet shall carry a unique identification number using the following pattern: PLNNN, where:
  • PL = Product leaflet identifier
  • NNN = Running serial number starting from 001
  • Example: PL001

• Each Inner Carton shall carry a unique identification number using the following pattern: ICNNN, where:
  • IC = Inner carton identifier
  • NNN = Running serial number starting from 001
  • Example: IC001

• Each Outer Carton shall carry a unique identification number using the following pattern: OCNNN, where:
  • OC = Outer carton identifier
  • NNN = Running serial number starting from 001
  • Example: OC001

• Each Shipper Carton shall carry a unique identification number using the following pattern: SHNNN, where:
  • SH = Shipper carton identifier
  • NNN = Running serial number starting from 001
  • Example: SH001

• Each BOPP Tape shall carry a unique identification number using the following pattern:
  • BONNN, where: BO = BOPP tape identifier
  • NNN = Running serial number starting from 001
  • Example: BO001

• Each QC Reagent shall follow the pattern: QRNNN, where:
  • QR = Quality Control reagent identifier
  • NNN = Running serial number starting from 001
  • Example: QR001

Accessories / Spares / Change Parts:

• Each General Accessory / Spares / Chage part shall follow the pattern: ACNNNN, where:
• • • AC = General Accessory / Spares / Chage part identifier
    • NNNN = Running serial number starting from 0001
    • Example: AC0001

• Each Production Accessory / Spares / Chage part shall follow the pattern: PACNNNN, where:
  • PAC = Production Accessory / Spares / Chage part identifier
  • NNNN = Running serial number starting from 0001
  • Example: PAC0001

• Each QC/QA Accessory / Spares / Chage part shall follow the pattern: QACNNNN, where:
  • QAC = Quality Control / Assurance Accessory / Spares / Chage part identifier
  • NNNN = Running serial number starting from 0001
  • Example: QAC0001

• Each Warehouse Accessory / Spares / Chage part shall follow the pattern: WACNNNN, where:
  • WAC = Warehouse Accessory / Spares / Chage part identifier
  • NNNN = Running serial number starting from 0001
  • Example: WAC0001

• Each Engineering Accessory / Spare / Change part shall follow the pattern: EACNNNN, where:
  • EAC = Engineering Accessory / Spares / Chage part identifier
  • NNNN = Running serial number starting from 0001
  • Example: EAC0001

• Each HR Accessory / Spares / Chage Part shall follow the pattern: HACNNNN, where:
  • HAC = HR Accessory / Spares / Chage part identifier
  • NNNN = Running serial number starting from 0001
  • Example: HAC0001

Equipment, Instruments, facility and Utilities:

• Each Equipment (Tablet Section) shall follow the pattern: T-NNN, where:
• • • T = Tablet section equipment identifier
    • NNN = Running serial number starting from 001
    • Example: T-023

• Each Utility System shall follow the pattern: U-NNN, where:
  • U = Utility system identifier
  • NNN = Running serial number starting from 001
  • Example: U-023

• Each Engineering Instrument shall follow the pattern: E-NNN, where:
  • E = Engineering instrument identifier
  • NNN = Running serial number starting from 001
  • Example: E-001
• Each Air Handling Unit (AHU) shall follow the pattern: AHU-NNN, where:
  • AHU = Air Handling Unit identifier
  • NNN = Running serial number starting from 001
  • Example: AHU-001

• Each Supply Riser of AHU shall follow the pattern: S/AHU-NNN/XX, where:
  • S/AHU = Supply riser connected to respective AHU
  • NNN = AHU number
  • XX = Riser branch number
  • Example: S/AHU-001/01

• Each Return Riser of AHU shall follow the pattern: R/AHU-NNN/XX, where:
  • R/AHU = Return riser connected to respective AHU
  • NNN = AHU number
  • XX = Riser branch number
  • Example: R/AHU-001/01

• Each Pressure Gauge shall follow the pattern: PG-NNN, where:
  • PG = Pressure Gauge identifier
  • NNN = Running serial number starting from 001
  • Example: PG-001

• Each Thermo-Hygrometer shall follow the pattern: TH-NNN, where:
  • TH = Thermo-Hygrometer identifier
  • NNN = Running serial number starting from 001
  • Example: TH-001

• Each Thermometer shall follow the pattern: TM-NNN, where:
  • TM = Thermometer identifier
  • NNN = Running serial number starting from 001
  • Example: TM-001

• Each Water System Loop shall follow the pattern: L-NN, where:
  • L = Water loop identifier
  • NN = Loop sequence number starting from 01
  • Example: L-01

• Each Room shall follow the pattern: D-NNN, where:
  • D = Room identifier
  • NNN = Running serial number starting from 001
  • Example: D-001

Batch Numbering and Date pattern:

• 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)

• Each Date in GMP records shall be written in the pattern: DD/MM/YYYY or DD/MM/YY, where:
  • DD = Date
  • MM = Month
  • YYYY or YY = Year
  • Example: 05/10/2025 or 05/10/25

• Each Manufacturing Date shall follow the pattern: MMM. YY or MM/YY, where:
  • MMM or MM = Month Indicator
  • YY = Last two digits of expiry year
  • Example: Sep. 25 or 09/25 (Manufacturing September 25)

• Each Expiry Date shall follow the pattern: MMM. YY or MM/YY, where:
  • MMM or MM = Month Indicator
  • YY = Last two digits of expiry year
  • Example: Sep. 25 or 09/25 (Expiry September 25)

REFERENCE:

• EU-GMP Part I, Chapter 4 – Documentation
• GMP Annex 15 – Qualification and Validation

RECORDS:

 REVISION HISTORY: