Validation process

Engineering
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Who should prepare the protocols for IQ, OQ and PQ?
What is the challenge part in PQ? Please give details.

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Generally, the qualification protocols (DQ, IQ, OQ) should be prepared by the supplier/fabricator/Validation service provider of equipment or system in co-ordination with the Engineering & Maintenance department (for example, Manufacturing equipment, Packaging machines, and utilities such as Purified water system, AHU / HVAC system, Compressed air, Nitrogen generator, etc.), while PQ protocol should be prepared by the user department (s).
All protocols should be reviewed by the user department(s), Engineering. And finally reviewed and Approved by Quality Assurance. A Qualification / Validation team should be established comprising of members from the User department, Engineering, QC, QA, and the supplier / Validation service provider. For software-related protocols, IT experts should be involved in the activities.

PQ / Validation challenges include framing of the protocol considering all practical aspects for actually manufacturing products / placebo runs and deciding the acceptance criteria. Regulatory requirements also should be considered.

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In agreement with sunilrbudhkar. Also consider that your organization must include these responsabilities and revisions within their procedures (SOP). Some organizations do not have this and have to deal with the risk of having suppliers making qualification protocols that are not fully aligned with the company’s policies or procedures; resulting in reworks or even deviations.

Also, consider due dilligance in auditing and qualifying any external entities hired for qualification and validation activities, in addition to equipment suppliers, making sure they are alligned with the regulatory frame applicable to your process.

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Absolutely true.
Thanks for your opinion. You are always welcome.

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Absolutely correct answer. IQ, OQ Protocol preparation & performed by equipment / instrument suppliers, PQ should be performed at users end.

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Thanks for your feedback. You are always welcome.

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