SOP for Analytical Reference Numbering System

OBJECTIVE

The objective of this SOP is to lay down the procedure for giving Analytical Reference Number (A.R. No.) for Raw Material, Packaging Material, Finished Product, Blend and Validation samples.

RESPONSIBILITY

Executive – Quality Control

ACCOUNTABILITY

Head – Quality Control

PROCEDURE

Raw Material:

• The A.R. No. is a unique code having 10 digits.
• For example: 5RA0028001
• First digit stands for the Year. specified Raw material
• Second to Seventh Digit stands for code of the specified Raw material.
• The eighth to tenth digit is serial number of consignment starting with “001”

PEOPLE ALSO READ: SOP for Good Laboratory Practices

Packing Material:

• The A.R. No. is a unique code having 10 digits.
• For example: 5PA0028001
• First digit stands for the Year. Specified Packing material
• Second to Seventh Digit stands for code of the specified Packing material.
• The eighth to tenth digit is serial number of consignment starting with “001”

Finished Product:

• The A.R. No. is a unique code having 12 digits.
• For example : 02C-1A/30156
• First two digits stands for the month of manufacturing.
• Third digit stands for the dosage forms i.e. C for Capsules, S for Dry Syrups, T for Tablets, I for Injection,
• The fourth digit is “-“
• Fifth digit “1” stands for Year 2021.
• Sixth digit “A” stands for XYZ Ltd.,
• Seventh digit is “/”.
• Then the advice sheet No. (Who is having five digits) shall be followed.

Blend / In-process:

• The A.R. No. is a unique code having 12 digits.
• For example : 2BC-5A/30156 / 2IC-5A/30156
• First digits stands for months for manufacture.
• Second digit stand for Blend /In-process.
• Third digit stands for the dosage forms i.e. C for Capsules, S for Dry Syrups, T for Tablets, I for Injection
• The fourth digit is “-“

• Fifth digit “1” stands for Year 2021.
• Sixth digit “A” stands for XYZ Ltd.,
• Seventh digit is “/”.
• Then the advice sheet No. (Who is having five digits) shall be followed.

Validation Samples:

• After location code there is “/” followed by “V”, which stands for validation sample followed by “/ ” and batch No.

Location Code:

INJ- Injection

TAB- Tablet

BET- Beta Lactam

CAP- Capsules

DRY- Dry syrup

ANNEXURES

Nil

REVISION HISTORY

Nil 

PEOPLE ALSO READ: SOP for Good Documentation Practice