Validation

Installation Qualification Protocol

The Validation & Compliance Services Group can develop Installation Qualification Protocols for each critical utility or piece of equipment. The protocol provides for a systematic method of checking the static attributes of the equipment before the equipment is used. The IQ will start with a description of the system. This description will describe what the system is intended to do, and all major components of the system. The system will be reviewed post-installation to verify the system is as specified in the user requirement, detail design specifications, engineering drawings, data sheets, and manuals. As part of the IQ all such documentation will be identified and referenced.

Operation Qualification Protocol

The Validation & Compliance Services Group can develop Operation Qualification Protocols to describe the operational and critical parameter testing required for proper operation of the system. Test objectives, methodologies, and acceptance criteria are defined and pre-approved. Prior to execution of the OQ, all critical Instrumentation (calibrated instruments) will be identified and documented. All control inputs are manipulated and control over each variable demonstrated and compared to the pre-approved design/acceptance criteria.

The protocols can also be used as a Dry Run prior to shipping the equipment. This will accomplish two important goals:

  • First, if something is wrong, we can discover it while the equipment is still under its full control at onsite where all the resources and personnel are readily available to deal with the situation.
  • Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.

Factory Acceptance Tests

The Validation & Compliance Services Group can develop Factory Acceptance Test protocols to provide documented evidence that a piece of equipment, system, or integrated process has been adequately tested at the manufacturer’s facility and performed to the end user’s expectations prior to being delivered to the end user. The FAT document will complete a series of verifications to ensure that what was ordered has been supplied by verifying the original purchase order and all specifications (URS, FRS, DDS) outlined, prior to the manufacture of the equipment, have been respected and incorporated on the finished product.

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  • Features & Options

    NJM Packaging’s validation support team is available to assist your in-house validation team with the development of comprehensive validation test protocols customized to your specific equipment, internal documentation format and functional requirements.

  • Specifications

    Our Line Integration specifications depend on the customers’ individual project needs. Contact NJM Packaging for more information.

  • Related Industries

    • Nutraceuticals
    • Pharmaceuticals

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