Conducting an operational qualification should follow an approved protocol. Critical operating parameters for equipment and systems should be identified during the OQ phase. OQ plans should identify the studies to be performed on the critical variables, the order of those studies and the measurement ...

1 According to GMP, each pharmaceutical company should identify what qualification and validation work is required to demonstrate that critical aspects of their specific operations are controlled. 2 The key elements of a company’s qualification and validation program should be clearly defined and ...

Operational qualification, or OQ, is an essential process often used by pharmaceutical companies during the development of equipment. OQ can be simply defined as a series of tests that ensure that equipment and its subsystems will operate consistently and reliably within their specified limits. In other ...

IQ is the method for confidently establishing that all major processing, packaging equipment and ancillary systems conform to installation specifications, equipment manuals, schematics and engineering drawings. This phase of validation includes equipment design testing, calibration determination, maintenance ...

Proving assurance is to make certain, provide confidence, and remove doubt or to be free from doubt. In the context of our industry, assurance can be achieved by observation or prediction. Observation or verification is the confirmation by examination and provision of objective evidence that specified ...

The act of proving and documenting that in any premises, systems and equipment are properly installed and/or function properly and lead to expected results. Qualification is often a part (primary stage) of validation, but individual qualification steps alone do not constitute process validation. A part ...