Operational Qualification Protocols

The Operational Qualification (OQ) verifies that the system or equipment operates in accordance with design specifications, manufacturer recommendations, and cGMPs. OQ testing is designed to simulate the full range of operating conditions to establish a system capabilities baseline and to ensure that the system operates as intended. 

Operational Qualification test functions include, but are not limited to, the following  

For equipment or systems controlled or monitored by a computer-related system, the functional testing cycle approach to computer validation is included and performed as part of the Operational Qualification. Functional testing verifies that the integrated hardware and software program perform in accordance with the functional specifications developed during the requirements phase. 

The Operational Qualification is performed in accordance with a preapproved written protocol. The specific Operational Qualification attributes to be verified during the performance protocol will be developed from the design specifications, manufacturer documentation, cGMP requirements, and other specific documentation. They, along with the acceptance criteria, will be approved as part of the protocol approval process. 

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A specihc operational qualification protocol shall be prepared for each piece of equipment undergoing operational qualification. 

Date OPERATIONAL QUALIFICATION PROTOCOL date of writing the protocol Paqe x (y) ... 

Table 3 Operational Qualification Protocol List of Essential Items... 

Once the system operational qualification protocol has been completed, the test results, data, and documentation are formally evaluated. The written evaluation should be presented clearly and in a manner that can be readily understood. The structure of the report can parallel the structure of the associated protocol. The report should also address any nonconformances encountered during the system operational qualification and their resolution. The system operational qualification report summarizes the results of the verification and testing of all technologies that are part of the system. 

Systems and equipment should operate correctly and their operation should be verified in accordance with an operational qualification protocol. 

This format is used for training purposes and reflects some of the possible contents for an operational qualification protocol. 

QA005 Operational qualification protocol format and requirements for software... 

IQ Installation Qualification protocol OQ Operational Qualification protocol PQ Performance Qualification protocol PV Process Validation protocol PM Preventive Maintenance procedure... 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

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