SOP for Allocating Document Protocol Number for Instrument Qualification : Pharmaceutical Guidelines

SOP for Allocating Document Protocol Number for Instrument Qualification

Standard operating procedure to allot the document number to the instrument qualification protocols.


       To provide a system for allocating document protocol number for instrument qualification in order to have a better tracebility and reference.      

2.0  SCOPE

       This SOP is applicable to instrument qualification protocol such as
       1.  User requirement specification
       2.  Functional requirement specification
       3.  Design qualification
       4.  Installation qualification
       5.  Operational qualification
       6.  Performance qualification
       7.  Re qualification


3.1  Doing      :  Quality control  department
3.2  Checking : Quality assurance department


       Head of the Department


Allot following system for document protocol number for instrument qualification.
5.2  Document protocol number                               Applicable for
       XXX/Q.C./000                                                      User requirement specification
                                                                                   Functional requirement specification
       XX/Q.C./000                                                         Design qualification
                                                                                   Installation qualification
                                                                                   Performance qualification
                                                                                   Re qualification
                                                                                   Operational qualification
       Where = XXX = Corresponds to three alphabets denoting the types of document protocols   
                      XX = Corresponds to two alphabets denoting the types of document protocol
                      000 = Corresponds to three numerical figure starting from 001
5.3  Allot following code for the protocol with respect to instrument qualification.

5.4  Instrument qualification protocol type                 Code 

       User requirement specification                                  URS
       Functional requirement specification                          FRS      
       Design qualification                                                 DQ
       Installation qualification                                           IQ
       Operational qualification                                           OQ
       Performance qualification                                          PQ
       Requalification                                                         RQ
6.1  SOP - Standard Operating Procedure

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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