SOP for Analytical Reference Numbering System

OBJECTIVE

The objective of this SOP is to lay down the procedure for giving an 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
• The first digit stands for the Year. specified Raw material
• Second, to Seventh Digit stands for the code of the specified Raw material.
• The eighth to tenth digit is the serial number of the consignment starting with “001”

ALSO READ: SOP for Preparation & Storage of Test Solution

Packing Material:

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

Finished Product:

• The A.R. No. is a unique code having 12 digits.
• For example 02C-1A/30156
• The first two digits stand for the month of manufacturing.
• The 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 “-“
• The fifth digit “1” stands for the Year 2021.
• The sixth digit “A” stands for XYZ Ltd.,
• The seventh digit is “/”.
• Then 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
• The first digits stand for months for manufacture.
• Second digit stand for Blend /In-process.
• The 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 “-“
• The fifth digit “1” stands for the Year 2021.
• The sixth digit “A” stands for XYZ Ltd.,
• The seventh digit is “/”.
• Then advice sheet No. (Who is having five digits) shall be followed.

Validation Samples:

After the 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 

ALSO READ: SOP for Qualifying Quality Control Personnel