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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…
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A new ASTM International standard, E 2555 , Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection, represents the latest work of a task group that is converting a series of old U.S. Department of Defense standards into ASTM documents. The task group is part of Subcommittee E11.30 on Data Analysis, which is under the jurisdiction of ASTM…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee E11 on Quality and Statistics has approved a new practice that describes methods for proficiency testing providers to use in analyzing laboratory results obtained in their programs. The standard, E 2489 , Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs, is under the jurisdiction of Subcommittee E11.20 on Test…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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Verifying the results of application software used to calculate the mechanical properties of materials is the subject of a new standard developed by ASTM International Committee E08 on Fatigue and Fracture. The new standard, E 2443, Guide for Verifying Computer-Generated Test Results Through the Use of Standard Data Sets, is under the jurisdiction of Subcommittee E08.03 on Advanced Apparatus and…
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Many structures, such as aircraft or other lightweight vehicles, are made from thin-ductile structural materials that exhibit low crack-front constraint, which allows for extensive plastic yielding of the material around a crack front. However, many current standards, such as E 399, Test Method for Linear-Elastic Plane-Strain Fracture Toughness K Ic of Metallic Materials, or E 1820, Test Method…
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Representatives of ASTM International will visit the campus of Southern Methodist University (SMU) in Dallas, Texas, on the evening of Nov. 9, 2005, for an hour-long presentation to university students interested in the field of fatigue and fracture. The session will focus on the technical standards currently in use by this discipline as well as the ability of students and professionals to be…