Qualification in the pharmaceutical industry encompasses a systematic process of demonstrating and documenting the suitability, competency, reliability, and compliance of personnel, equipment, processes, systems, and facilities against predefined requirements, specifications, or standards. This process may involve a range of activities, including training, education, certification, testing, validation, or accreditation, to ascertain competence, proficiency, and adherence to regulatory or industry benchmarks. The objective of qualification is to ensure that all personnel, facilities, utilities, and systems are adequately equipped and capable of executing their designated functions effectively, safely, and in compliance with quality standards, ultimately contributing to the overall product quality and regulatory compliance.
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