Numbering System of Validation Documents

1.0    PURPOSE 

         To lay down the procedure of numbering system for validation documents.

2.0    SCOPE 

2.1    This procedure is applicable to all the Validation documents pertaining to Quality Assurance, Quality Control, Production and Engineering Departments.

3.0    RESPONSIBILITY

3.1    Executive – Quality Assurance

4.0    ACCOUNTABILITY

4.1    Head – Quality Assurance

5.0    PROCEDURE

5.1    Number Assignment system of Validation document:

    
5.1.1    Validation document type and code

Following different types of validation documents shall be prepared and indicated by the different document code as mentioned below.
 
5.1.1.1    Document Type 

?    User requirement specification            :    UR
?    Data sheet (FRS)                    :    DT
?    Design Qualification                :    DQ 
?    Installation Qualification                :    IQ
?    Operation Qualification                :    OQ
?    Performance Qualification            :    PQ

Version number shall be ‘00’ for initial qualification, and 01, 02, 03… are for corresponding re-qualifications.

1. Document Type           
2. Master Validation Plan

5.1.1.3    Document Type 

?    Master Process validation      :    MPV
?    Holding Time Study                :    HTS

5.1.1.4    Document Type 

?    Cleaning Validation                    :    CV
?    Sterility and Microbial count related Validation*    :    SV
?    Area cleaning and disinfectant related Validation    :    AV

*Sterility and dehydrogenation related validation consist of steam sterilization, Dry heat sterilization, Endotoxine recovery, Microbial count and dehydrogenation method, etc. 

5.1.1.5    Document Type 

?    Computer System Validation

Document Type

?     Analytical Method Validation

                                                                   END OF DOCUMENT

Numbering system, validation documents,quality assurance