Quality Management System in Pharmacy

Pharmaceutical quality management system cGMP ICH Q1 multiple industries

Authors

  • Ikbol Mahmudova Nematovna Head of the Expertise Department at the State Institution "Center for Good practices" of the Agency for the Development of the pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan, Master's degree, Republic of Uzbekistan, Tashkent Region
  • Nizom Davurovich Suyunov Head of the Department of pharmaceutical Organization, Tashkent pharmaceutical Institute of the Ministry of Health of the Republic of Uzbekistan, Doctor of pharmaceutical Sciences, Republic of Uzbekistan, Tashkent City,
November 30, 2025

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A systematic system of rules, procedures, and activities known as a pharmaceutical quality management system (QMS) guarantees that pharmaceutical goods continuously satisfy quality standards and legal requirements from creation through production and distribution. It includes all actions taken to ensure the quality, safety, and effectiveness of the product, such as quality control, quality assurance, risk management, and documentation. These actions are frequently in line with current Good Manufacturing Practices (cGMP) and ICH Q1. A Quality Management System (QMS) is a structured framework of processes, roles, and resources meant to ensure customer and regulatory compliance, as well as consistent quality and services across multiple industries. A pharmaceutical quality management system (QMS) is an organized collection of recorded procedures, roles and assets that guarantee the reliable manufacturing and management of pharmaceutical goods. Requirements like ISO 9001, FDA 21 CFR Parts 210 and 211, ICH Q10, EU GMP, and PIC/S GMP govern pharmaceutical QMS. An electronic Quality Management System (eQMS) can be used by pharmaceutical companies to improve traceability, expedite QMS procedures, and guarantee compliance with relevant regulations. Simpler QMS is a cloud-based, verified eQMS for the pharmaceutical business that centralizes document control, streamlines CAPA, training, audit management, and other critical procedures, and simplifies compliance with ISO 9001, FDA 21 CFR Parts 210 and 211, ICH Q10, EU GMP, and PIC/S GMP

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