Equipment Qualification
From WikiBioPharm
There are common requirements for the qualifications of equipment:
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Installation Qualification
The Installation Qualification (IQ) will confirm details from the engineering specifications, equipment purchase order and CGMP guidelines and requirements, as well as verifying the equipment has been installed as specified by the vendor of the equipment. Usually equipment is totally installed; installation punch lists are complete; start-up activities are completed and any deficiencies have been corrected. The pre-approved IQ protocol lists the equipment requirements, and the vendor installation requirements. The IQ documents the existence and location of equipment documentation. During each IQ, equipment design, construction and materials of construction is verified against engineering specifications, purchase requirements and GMP issues. The piece of equipment is examined to confirm proper connection and installation of the supporting services and components relative to vendor specifications. The location of all appropriate support documentation (such as manufacturer's manuals, purchase orders, test results, spare parts lists, certificates) is referenced. Manufacturer's tag data is collected.
Operational Qualifications
The Operational Qualification (OQ) is developed in two sections; the verification section includes equipment information not included in the IQ, and the functional tests section details the tests performed on the equipment to document it operates correctly. Several prerequisites must be met before the OQ is performed: completion of the IQ; verification that deficiencies have been resolved and the protocol has been updated and approved; verification of the availability of OQ support utilities; verification all calibrations have been completed; identification of test equipment; and verification of the current calibration status and NIST traceability of the test equipment.
Performance Qualifications
The Performance Qualification (PQ) performs two separate functions: the first is equipment related, the second is related to a specific step or steps during product production. PQ activities are conducted on critical systems, to demonstrate and document the equipment is able to perform its intended functions within the variable process limits for a specific product. Acceptance criteria are developed according to the regulatory requirements and production parameters to ensure the quality and purity of the product is maintained. PQ testing includes, but is not limited to, activities such as sterilization/sanitization. Usually a minimum of three successful consecutive test runs are required for this purpose. The PQ process may also include several challenges to the system challenging the operating limits. This testing provides confidence that the equipment will function properly during reasonable adverse conditions.
