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Standard operating procedure for qualification of equipment, machines and systems including installation, operational and performance qualification.
1.0 PURPOSE
To lay down the procedure for equipment/machines and system qualification.
2.0 SCOPE
This procedure is applicable for all the equipment’s and machines, installation, Operation and Performance and to establish Standard at first place.
3.0 RESPONSIBILITY
Doing: User/Owner Department, Engineer and QA Executive
Review: Production, Engineering, Quality control
Approval: Quality Assurance
4.0 ACCOUNTABILITY
All Department Heads
5.0 PROCEDURE
Equipment/System qualification should include following :
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
6.0 ABBREVIATIONS
6.1 EQ: Equipment/Machine Qualification Protocol
6.2 IQ: Installation Qualification
6.3 OQ: Operational Qualification
6.4 PQ: Performance Qualification
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