QRM

Change Management System In Pharmaceutical Industry

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Change Management System in Pharmaceutical Industry: Complete Guide (2026) Change Management System in Pharmaceutical Industry: Complete Guide (2026) The pharmaceutical industry operates in one of the most highly regulated environments in the world. Every modification made to a manufacturing process, facility, equipment, computer system, analytical method, supplier, packaging material, or documentation has the potential to … Read more

QUALITY RISK ASSESSMENT

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Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards as defined below. Quality risk assessments begin with a well-defined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool and the types of information needed … Read more

BASIC UNDERSTANDING OF QUALIFICATION, CALIBRATION AND PREVENTIVE MAINTENANCE:

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QUALIFICATION: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended. All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification. After successful completion of qualification exercise, the Equipment / instrument / Utilities … Read more