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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…
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Information and product destruction services is a rapidly growing industry. In order to develop standards to serve the needs of this industry, ASTM International Committee E34 on Occupational Health and Safety has formed Subcommittee E34.25 on Mobile and Plant-Based Security Destruction Equipment Safety Requirements. All interested parties are invited to participate in the standards developing…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…
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An important standard that is used to help protect the health of workers where there may be occupational exposure to quartz dust has recently been revised. ASTM standard E 1132 , Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, was developed by Subcommittee E34.16 on Silicas, which is under the jurisdiction of Committee E34 on Occupational…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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A revolutionary new ASTM International standard will change the way in which healthcare professionals preserve and transfer healthcare information about their patients. The standard, E 2369, Specification for Continuity of Care Record (CCR), was developed by Subcommittee E31.28 on Electronic Health Records, which is under the jurisdiction of Committee E31 on Healthcare Informatics. The Continuity…
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ASTM International Committee E31 on Healthcare Informatics has approved a new standard that will aid in defining the application of existing conventions for the structure and content of electronic health record systems that are used to support healthcare practitioners in a workplace setting. The standard, E 2473, Guide for the Occupational/Environmental Health View of the Electronic Health Record…
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A new standard developed by ASTM International Committee E34 on Occupational Health and Safety will provide foundries with a comprehensive set of safety requirements. The standard, E 2349, Practice for Safety Requirements in Metal Casting Operations: Sand Preparation, Molding, and Core Marking; Melting and Pouring; and Cleaning and Finishing, is under the jurisdiction of Subcommittee E34.20 on…