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ASTM International’s Committee on Accreditation and Certification (E36) has presented its top annual award – the Award of Merit – to Peter Unger of A2LA in Frederick, MD., U.S.A. The prestigious award, which includes the accompanying title of fellow, is ASTM’s highest recognition for individual contributions to developing standards. The committee honored Unger for outstanding service, significant…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10129
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Leo J. Titus, Jr., president of ECS Mid-Atlantic, LLC, in Chantilly, Va., has been named chairman of ASTM International Committee E36 on Accreditation & Certification . Formed in 1973, E36 has nearly 150 members and includes 5 technical subcommittees that oversee 8 standards related to operation and recognition of accreditation bodies and conformity assessment entities for calibration and…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10036
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ASTM International’s Committee D09 (Electrical and Electronic Insulating Materials) invites anyone to join in developing a new standard to help maintain the integrity of cables during an emergency such as a fire. Specifically, the proposed standard (WK52230, Test Method for Determination of Acid Gas Content of Wire and Cable Insulation or Jacket Material) will help determine the halogen content…, ASTM Committee D09 Next Meeting:, April 14-15, 2016, April Committee Week, San Antonio, Texas, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Larry Ingram, Williamsport, Pa., tel +1.570.916.8448; larry77151@comcast.net , ASTM Staff Contact:, Katerina Koperna, tel +1.610.832.9728; kkoperna@astm.org Release #9960
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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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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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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…