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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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ASTM International Committee B10, on Reactive and Refractory Metals and Alloys will hold its upcoming meeting Nov. 16-17, at the Mercure Hotel Ronceray Opera, in Paris, France. Committee meetings will be held Nov. 16, while presentations and a tour of the CEA/Saclay Research Center will occur on Nov. 17. In addition to regular B10 activities, the November meeting will include special presentations on titanium, zirconium and…
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A former military standard has become the basis for a new ASTM standard developed by Committee E11 on Quality and Statistics. The new standard, E 2234, Practice for Sampling a Stream of Product by Attributes Indexed by AQL, will be the first in a series based on a now-withdrawn set of military documents on sampling. Practice E 2234, presently under the jurisdiction of Subcommittee E11.10 on…