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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive ...
The Healthcare Sterile Processing Association (HSPA), formerly International Association of Health Central Service Material Management (IAHSCMM), [3] is a professional association which represents healthcare Central Service (CS) professionals, and is based in Chicago, Illinois with over 48,000 [4] members worldwide.
WHO Expert Committee on Biological Standardization is a functioning body of World Health Organization.The Expert Committee has been meeting annually since 1947. The Committee reports are published as WHO Technical Report Series, available online.
(Reuters) -One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules meant to ensure drugs are free ...
Grand River Aseptic Manufacturing (GRAM) is a clinical and commercial sterile manufacturing contractor to the pharmaceutical industry. It has lyophilization , terminal sterilization, analytical, microbiological testing services.
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
Catalent, Inc. (Catalent Pharma Solutions) is a multinational corporation headquartered in Somerset, New Jersey.It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products.