Qualifications Protocol

Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals.

Quality Assurance

Operational Qualification (OQ) In Pharmaceuticals. Systems and equipment should operate correctly and their operation should be verified in accordance with an operational qualification protocol. Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances (also referred to as “worst case conditions”). Operational qualification …

Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals. Read More »

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

Quality Assurance

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals.   Installation Qualification:- Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. Requirements for calibration, maintenance and cleaning should be drawn up during installation. Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges …

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals   Read More »