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ASTM International has published a new American National Standard, ASTM E2659 , Standard Practice for Certificate Programs. This standard provides much-needed guidance to certificate issuers on how to develop a quality certificate program and to consumers on how to identify such a program. In addition, the standard is designed to serve as the benchmark of quality for industry accreditation of…
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All interested parties are invited to attend the first meeting of ASTM International Subcommittee E36.30 on Personnel Certificate Programs on June 23 at the Hyatt Regency Convention Center in Denver, Colo. The new subcommittee is part of ASTM International Committee E36 on Laboratory and Inspection Agency Accreditation, which will be meeting in Denver June 23-24. ASTM Subcommittee E36.30 will…
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A new ASTM International standard provides guidance for using data generated by ASTM standards in testing for asbestos in surface dust. ASTM D 7390 , Guide for Evaluating Asbestos in Dust on Surfaces by Comparison Between Two Environments, was approved by ASTM International Committee D22 on Air Quality, part of Subcommittee D22.07 on Sampling and Analysis of Asbestos. According to James Millette…
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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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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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A new ASTM International standard will provide a method to consistently address indoor air quality complaints in residential buildings and to guide IAQ investigations in an efficient manner. The standard, D 7297 , Practice for Evaluating Residential Indoor Air Quality Concerns, is under the jurisdiction of Subcommittee D22.05 on Indoor Air, part of ASTM International Committee D22 on Air Quality…
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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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Laboratories that measure fibers in workplace samples will be the most likely users of two new ASTM International standards: D 7200 , Practice for Sampling and Counting Airborne Fibers, Including Asbestos Fibers, in Mines and Quarries, by Phase Contrast Microscopy and Transmission Electron Microscope; and D 7201 , Practice for Sampling and Counting Airborne Fibers, Including Asbestos Fibers, in…
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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…