NEWS

Qualification of Instruments/Equipment

Everything needs to be documented –Created by users, manufacturers, or by collaboration between the two –However, the final responsibility rests with the user (FDA’s stance)
・The selection of a reliable manufacturer is important (the user’s stance)
1). DQ, Design Qualification
2). IQ, Installation Qualification
3). OQ, Operational Qualification
4). PQ, Performance Qualification

Ministry of Health and Welfare GMP (Good Manufacturing Practice)  1st chapter 1st article says

Validation means to verify that Procedure or Manufacturing Process or other methods of Manufacturing Management and Quality Controlgive the expected results, and to make documentation.. 

Everything needs to be documented

  • Created by users, manufacturers, or by collaboration between the two
  • However, the final responsibility rests with the user (FDA’s stance)
  • The selection of a reliable manufacturer is important (the user’s stance)

Types of Qualification

  • DQ, Design Qualification
  • IQ, Installation Qualification
  • OQ, Operational Qualification
  • PQ, Performance Qualification

   At least IQ/OQ/PQ are necessary

  • Before Delivery

DQ created by the user: the manufacturer provides the catalogues and reference materials

  • At Delivery

Implementation of IQ/OQ, confirmation of maintenance procedures

  • Periodic Maintenance

Carrying out maintenance and log recording, implementation of OQ/PQ

  • When the Composition of the System is Changed

Implementation of IQ/OQ, confirmation of maintenance procedures

  • When Repairing Faults

Repairs, implementation of OQ, recording the maintenance log

  • When Exchanging Consumables

Implementation of OQ/PQ, filling in the maintenance log

Below Services are available:

  • Installation Qualification, Operational Qualification & Performance Qualification.
  • Calibration of equipments.

Please contact us for any type of qualification/calibration Services

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