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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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Aluminum sheet products are used around the world in a wide array of applications, from aircraft, automobiles and light rail cars to cans, foil and building materials. The standard that describes shear testing for such aluminum sheets, ASTM B831 , Test Method for Shear Testing of Thin Aluminum Alloy Products, has recently been revised to include testing procedures for a wider range of uses. “ASTM…, ASTM Committee B07 Next Meeting:, Nov. 10-12, 2014, November Committee Week, New Orleans, La., Technical Contact:, Jidong Kang, Natural Resources Canada, Hamilton, Ontario, Canada, Phone: 905-645-0820; jkang@nrcan.gc.ca, ASTM Staff Contact:, Kristy Straiton, Phone: 610-832-9640; kstraiton@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9668
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Performance tests of potential personnel are becoming more commonly used as predictors of on-the-job performance. A new ASTM International standard is focused on 42 issues that are specific to personnel performance test development and implementation. ASTM E2849 , Practice for Professional Certification Performance Testing, was developed by Subcommittee E36.80 on Personnel Performance Testing and…, ASTM Committee E36 Next Meeting:, June 23-24, 2014, June Committee Week, Toronto, Ontario, Canada, Technical Contact:, Wallace Judd, CertNT LLC, Leesburg, Va, Phone: 703-884-2222 (ext. 802); wallace@wallacejudd.com, ASTM Staff Contact:, Rick Lake, Phone: 610-832-9689; rlake@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9565
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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A new standard approved by ASTM International Committee B07 on Light Metals and Alloys provides an outline for designers, casting purchasers, casting producers and technical societies on how to do business when purchasing squeeze, thixocast or rheocast parts. The new standard, B969 , Specification for Aluminum-Alloy Castings Produced by the Squeeze Casting, Thixocast and Rheocast Semi-Solid…
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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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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…