Qualification process

dear validation team,
in the qualification process, the first thing we do is filling the data that required in IQ, OQ, PQ in the manufacturer Document after that I have to make a report related to my company and to prove the manufacturer Document is enough for qualified the equipment so can any help me how the report is or you can share your ideas??

  • I’m not sure if the report is necessary for auditors.
    Best regards

You can give your protocol to the equipment manufacturer for the IQ and OQ.
Be sure that the Manufacturer fills in all the blanks and signs and dates it with his Company Stamp.
In that way you are not duplicating your work.
The PQ has to be in your format and is the only document that can be discussed with any auditor.

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so you suggest to make only PQ signs by my company

•Draft or update risk assessment of your process.
•Draft or update user requirements specifications (URS) to document what you want the equipment to be able to do.
•DQ: verify using the equipment specifications if the proposed equipment meets the requirements in the URS. URS+DQ are to be done prior to purchase.
•Installation qualification (IQ): to ensure the equipment is installed properly and if you have everything (all parts, cables, user guide, CE certification etc.)
•Operational qualification (OQ): to ensure the equipment functions as the manufacturer intended. (so according to specifications)
•IQ/OQ is often performed by or purchased from the supplier, be sure to review the protocol before execution and add any aspects of your URS that are relevant.
•Performance qualification (PQ): to ensure that the equipment is able to run your processes. What tests to performs is based on your risk assessment. Be sure that all aspects of your URS are addressed.
•Draft validation summary report: summarize all activities above, including deviations and CAPA if necessary. Conclude with release statement (can the equipment be used by QC and for what)

ALL documents must be approved by your company, including those generated by the supplier

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