MHPM H P C O N S U L T A N T S, L L C

IQ/OQ/PQ

Installation Qualification, Operational Qualification, and Performance Verification of equipment and instruments is a vital link in the quality chain.  One of the major areas of focus for both FDA (or any other regulatory body) and client audits.  All equipment and instruments must meet manufacturer's or preset standards for operation and performance.

Installation Qualification does not just apply to a brand new piece of equipment or instrument.  A used instrument or piece of equipment that is new to the site must also undergo installation qualification.  Movement of equipment or instruments requires re-Installation Qualification to ensure proper operation.  Many new pieces of equipment and instruments include either instructions for IQ or options for the manufacturer to perform IQ for you.  MHP Consultants can step you through this confusing process for either performing in-house (with a manufacturer's supplied IQ or MHP Consultants developed IQ) or review the manufacturer's IQ process to ensure the applicability and validity of the IQ.

Operation Qualification and Performance Verification must be perform at least annually for every piece of equipment or instrument.  Most manufacturers have provisions for performing these services, at a cost.  This can be confusing, time consuming and costly to allow the manufacturer to perform. MHP Consultants can alieviate this headache by training you in-house staff to perform these services through the development of Standard Operating Procedures and transfer training.  This allows the freedom to schedule the necessary maintenance without third-party scheduling.

Performance Verification is also necessary for movement of equipment and instruments to prove the operation prior to and after the movement of said equipment and instruments.  MHP Consultants can set up a Standard Operating Procedure for this verification and train your in-house staff in its proper execution.

For further information or specific needs please contact us at iq_oq_pq@mhpconsultants.com

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