ORGANIZATION OF MEDICINE QUALITY CONTROL IN PHARMACEUTICAL MANUFACTURING ENTERPRISES
Keywords:
Quality control, system of drug business, medications, serious ramifications, guarantees.Abstract
The quality control of medicines produced by pharmaceutical manufacturing enterprises is of paramount importance. Given the significant impacts medications can have on human health and well-being, it is imperative that strict quality standards are established and diligently enforced throughout the entire production process. This ensures medications are both safe and effective for their intended medical purposes. To organize effective quality control, pharmaceutical enterprises must implement a robust organizational structure and procedures. At the top of this structure should be a Chief Quality Officer or similar senior executive role dedicated solely to overseeing all aspects of quality assurance. This individual is responsible for developing comprehensive quality policies and protocols, as well as monitoring compliance to safeguard patient safety. Reporting to the CQO should be multiple quality control managers who supervise quality inspectors, analysts and technicians working in production and testing facilities. This article will explore the system of quality control in pharmaceutical enterprises.
References
Quality confirmation of drugs. A summary of rules and related materials. Vol. 2, second refreshed release. Great assembling practices and investigation. Geneva, World Wellbeing Association, 2007.
Global Association for Normalization. General prerequisites for the ability of testing and alignment research centers. ISO/IEC 17025:2005.
Model certifi cate of investigation. In: WHO Master Panel on Determinations for Drug Arrangements. Thirty-6th report. Geneva, World Wellbeing Association, 2002, Addition 10 (WHO Specialized Report Series, No. 902).
Worldwide jargon of metrology — Essential and general ideas and related terms. VIM third ed., Joint Council for Guides in Metrology (JCGM) 200:2008 (http://www.bipm.org/utils/normal/records/jcgm/JCGM_200_2008.pdf).
Direction for industry — Researching out-of-specifi cation test results for drug creation. US Food and Medication Organization, Place for Medication Assessment and Exploration (CDER), October 2006 (http://www.fda.gov/downloads/Medications/GuidanceComplianceRegulatoryInformation/Directions/UCM070287.pdf).
Rules for examination of medication appropriation channels. In: WHO Master Panel on Specifi cations for Drug Arrangements. Thirty-fi fth report. Geneva, World Wellbeing Association, 1999, Addition 6 (WHO Specialized Report Series, No. 885).
Great assembling rehearses: valuable rules for the production of drug excipients. In: WHO Master Board of trustees on Specifi cations for Drug Arrangements. Thirty-fi fth report. Geneva,World Wellbeing Association, 1999, Addition 5 (WHO Specialized Report Series, No. 885).