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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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Keeping birds away from potentially fatal encounters with building exteriors is the purpose of a proposed new ASTM International standard, ASTM WK47853 , Test Method for Bird Collision Deterrence Material Threat Factor. It is possible that as many as a billion birds are killed every year after colliding with glass on buildings, including many single-family homes — and this is in the United States…, ASTM Committee C14 Next Meeting:, April 14, 2015, Moorestown, N.J., Technical Contact:, Stefan Knust, Ennead Architects, New York, New York, tel +1.212.807.7171; sknust@ennead.com, ASTM Staff Contact:, Thomas O’Toole, tel +1.610.832.9739; totoole@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9767
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European Commission and European Aviation Safety Agency Endorse Aviation Modernization Initiative, Both the European Commission and the European Aviation Safety Agency (EASA) have endorsed a global initiative to modernize the way smaller airplanes are certified. The initiative, “CS23/Part 23 Reorganization,” will lead to the world’s aviation authorities each modernizing their own certification rules. The initiative is based on 16 draft standards currently being developed by ASTM International…, Shown from left to right, at the "Shaping the Future of General Aviation Products in Europe" workshop in Brussels are Boudewijn Deuss, rulemaking officer, EASA; Gregory Bowles, director, European Regulatory Affairs and Engineering, GAMA, and ASTM F44 chairman; Yves Morier, head of GA Unit, EASA; Sara Gobbi, director of EU Affairs, ASTM; Christine DeJong, manager, ASTM; and Filip Cornelis, head of…, ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit www.astm.org/JOIN. For more news in this sector, visit www.astm.org/sn-transportation or follow us on Twitter @ASTMTransport., ASTM Committee F44 Next Meeting:, Jan. 27-30, 2015, January Committee Week, New Orleans, La., 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 #9679
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ASTM International, at the request of the National Business Aviation Association (NBAA), will hold an organizational meeting to explore the establishment of a new ASTM standards development activity for aerospace personnel. The no-fee meeting is scheduled for Tuesday, Dec. 2, 2014, and will take place at NBAA in Washington, D.C. Key stakeholders are invited to participate with the goal of…, ASTM Aerospace Technician Meeting:, Dec. 2, 2014, NBAA Office, 1200 G St. NW, Suite 1100, Washington, D.C., 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 #9673
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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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New ASTM Committee F44 to Develop Standards That Will Streamline Certification Process, Empower Innovation, ASTM International announces the formation of Committee F44 on General Aviation Aircraft , bringing together global stakeholders to work on a standards roadmap that will help transform the way smaller aircraft are manufactured and certified around the world. The new ASTM Committee F44 was formed at the request of aviation industry organizations in support of the efforts of the Federal Aviation…, Driving Change through ASTM Consensus Standards, The efforts of Committee F44 will play a critical role in supporting the overhaul of Part 23 regulations into what the FAA envisions as more of a performance-based document. Industry-driven F44 standards for the design and airworthiness of general aviation aircraft will serve to better align aircraft certification requirements with the type of operation the aircraft will experience. “Simplified,…, ASTM International: Global Heritage in Aviation Standards Development, ASTM’s broad portfolio of aviation-related standards has been created through the work of its existing technical committees dedicated to the field, including F07 on Aerospace and Aircraft , F37 on Light Sport Aircraft and F39 on Aircraft Systems . More than 20 Committee F37 standards have been cited by the FAA in regulations governing light sport aircraft. Similar to the membership of the Part 23…, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler; Phone: 610-832-9603; bschindl@astm.org R elease #9242
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ASTM International, in support of efforts stemming from the Part 23 Reorganization Aviation Rulemaking Committee (ARC), will host an organizational meeting for the establishment of a new ASTM standards activity on general aviation (GA) airworthiness design standards. The meeting will be held Sept. 17, from 1:00 p.m. to 4:00 p.m. EST, at the Aircraft Electronics Association headquarters in Lee’s…, Next Meeting:, Sept. 17 at AEA headquarters and Oct. 26 in Atlanta, Ga., ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9277
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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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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…