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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 ASTM International subcommittee will develop standards for management of property connected by contract with entities of the U.S. federal government. Subcommittee E53.20 on United States Government Contract Property Management is under the jurisdiction of ASTM International Committee E53 on Property Management Systems. According to Brandon Kriner, manager of Asset Management, Harris Corp.’s…
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A recent revision to an ASTM International property management systems standard provides clarity on the use of the word “inventory” and allows for the electronic verification of assets within an organization. The revised standard, ASTM E2132 , Practice for Inventory Verification: Electronic and Physical Inventory of Assets, is under the jurisdiction of Subcommittee E53.01 on Process Management ,…, Technical Contact:, Rick Shultz, Johns Hopkins University, Laurel, Md., Phone: 443-778-5585; richard.shultz@jhualpl.edu, ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicarie@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9096
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Movement, shipment and transfer are all words that are commonly used by entities that deal with tangible property. To ensure that these words are being used and understood by all parties involved, ASTM International Committee E53 on Property Management Systems has approved a new standard, ASTM E2671 , Practice for Defining Movements, Shipments and Transfers of Tangible Property. ASTM E2671 was…
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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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Any organization that owns and uses a variety of equipment must find ways to identify it and track its movement. A new standard and a proposed new standard being developed by ASTM International Committee E53 on Property Management Systems focus on these aspects of equipment ownership. The new ASTM standard, E2606 , Practice for Receipt Notification as a Result of Tangible Property Movement, and…
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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…