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.

1.0 OBJECTIVE

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. Requalification

3.0 RESPONSIBILITY

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

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

Allot the following system for document protocol number for instrument qualification.
5.2 Document protocol number applicable for-
XXX/Q.C./000 - User requirement specification and Functional requirement specification
XX/Q.C./000 - Design qualification, Installation Qualification, Performance Qualification
Requalification and 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 codes-
User requirement specification - URS
Functional requirement specification - FRS 
Design qualification - DQ
Installation qualification - IQ
Operational qualification - OQ
Performance qualification - PQ
Requalification - RQ

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

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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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