PROCEDURE FOR MICROBIOLOGY VALIDATION DOCUMENTATION CODIFICATION

1.0 OBJECTIVE
To lay down guidelines for codification of validation documents in microbiology.
2.0 SCOPE
This SOP is applicable to Quality Control Department, Formulations Units
3.0 RESPONSIBILITY
Quality Control chemist / Executive
4.0 ACCOUNTABILITY
Departmental Head
5.0 PROCEDURE
5.1 Codification System consists of eleven characters AXXMBYYAAZ and are as follows
5.1.1 A character represents the location , specified as – Numeric follows
1 - For Formulation Unit 1
2 - For Formulation Unit 2
3 - For Formulation Unit 3
5.1.2 XX character represents the category specified as under : Alphabetical
VP : Validation Protocol
ST : Sterility testing
BT : Bacterial endotoxin test
MT : Microbial limit test
5.1.3 MB stands for microbiology.
5.1.4 YY character represents the protocol number, specified as – Numeric follows 01,02 and so on
5.1.5 Z character represents the Revision Number, specified as – Alphabetical
Follows - first time any format is prepared, the revision number shall be ‘A’. The next revision would be ‘B’ and so on.
5.1.6 For reference example is as follows,
Protocol number for validation will be given as 2VPMB01A.
Where,
2 stands for formulation Unit 2
VP stands for validation protocol
MB stands for Microbiology
01 stands for first protocol number
A stands for revision number.

The above SOP is only a guideline for the users and shell be suitably changed according to their company.