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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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Three proposed ASTM International standards will provide a base for the evaluation of the antimicrobial efficacy of solid copper materials. The proposed standards are being developed by Subcommittee B05.06, Methods of Test, part of ASTM International Committee B05 on Copper and Copper Alloys . The three proposed standards are: • ASTM WK42235 , Test Method for Efficacy of Copper Alloy Surfaces as…, ASTM Committee B05 Next Meeting:, Oct. 21-23, 2013, October Committee Week, Jacksonville, Fla., Technical Contact:, James H. Michel, Copper Development Association Inc., New York, N.Y., Phone: 212-251-7210; j ames.michel@copperalliance.us, ASTM Staff Contact:, Jennifer Rodgers, Phone: 610-832-9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9439
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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 newly approved ASTM copper standard focuses on the mechanical properties of machining brasses. ASTM B981/B981M , Specification for Low Leaded Brass Rod, Bar and Shapes, was developed by Subcommittee B05.02 on Rod, Bar, Wire, Shapes and Forgings , part of ASTM International Committee B05 on Copper and Copper Alloys . “Since 1997, there has been increasing legislation, regulation and voluntary…, ASTM Committee B05 Next Meeting:, April 15-17, 2013, April Committee Week, Indianapolis, Ind., Technical Contact:, Larry Muller, Chase Brass and Copper Co., Montpelier, Ohio, Phone: 419-485-8932; lmuller@chasebrass.com, ASTM Staff Contact:, Jennifer Rodgers, Phone: 610-832-9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9307
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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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ASTM International Committee B05 on Copper and Copper Alloys has created a new task group, TG9018, which will be focused on the Antimicrobial Applications of Copper and Copper Alloys. The task group was formed following the U.S. Environmental Protection Agency's announcement of its registration of copper alloys as antimicrobial materials with specific health claims. According to James Michel,…
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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…