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A new ASTM International standard could help pharmaceutical manufacturers support product quality through sampling done with certain instruments. ASTM International’s committee on manufacturing pharmaceutical and biopharmaceutical products ( E55 ) developed the new standard ( E3177 ), which covers both the sample from which data is taken and the sample that is taken for reference. “This standard…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10650
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Members of the ASTM International cannabis committee ( D37 ) are proposing two guides for cannabis sampling procedures in an effort to ultimately improve consumer safety. The guides cover concentrates, extracts, and other cannabis-infused products (WK64646) as well as harvest lots and usable cannabis products (WK64336). Members say the new standards will provide sampling procedures critical in…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10629
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Members of the ASTM International cannabis committee ( D37 ) are proposing a standard for managing and implementing what are called “hazard analysis critical control points” (HACCP) systems for cannabis processing. HACCP systems are already used in the food industry to prevent, control, or reduce to an acceptable level potential hazards to consumers. “These systems can apply to manufacturing…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10627
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ASTM International’s cannabis committee ( D37 ) is developing a guide for quality management systems (QMS) that provide a framework for organizations dealing with cannabis consumer products. The standard ( WK61355 ) provides a guideline to show an organization’s ability to provide cannabis-related products or services that meet consumer safety standards along with local and state regulatory…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10617
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A new ASTM International subcommittee will focus on industrial hemp. The group (D37.07) will be part of ASTM’s newly formed cannabis committee ( D37 ). According to organizers, the subcommittee plans to develop practices and guides relevant to industrial hemp, a variety of the cannabis sativa plant species. Industrial hemp is used for many applications including food, natural health products,…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10608
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ASTM International’s cannabis committee (D37) is working to develop a voluntary standardized practice ( WK63546 ) that will outline how producers can respond when products need to be recalled or removed from the market. ASTM International member Cary Black, a consultant at Orion GMP, notes that many cannabis products are designed for human consumption, so product safety and quality are critical…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10589
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A new guide proposed by ASTM International’s cannabis committee (D37) will help organizations in the industry to develop their own internal Corrective Action/Preventive Action (CAPA) processes and procedures. CAPA systems are a key part of quality management, according to committee members. Specifically, CAPA systems focus on investigating, understanding, and correcting discrepancies to prevent…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10586
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ASTM International’s cannabis committee ( D37 ) is developing a proposed standard that will provide recommendations for laboratories involved in the industry. According to members, the standard (WK63913) will outline best lab practices, recommended certifications, various types of analyses, and the quality assurance functions for labs working with cannabis. Cary Black, consultant for Orion GMP,…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Robert Morgan, tel +1.610.832.9732; rmorgan@astm.org Release #10581
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A new standard from ASTM International’s committee on quality and statistics (E11) addresses general reliability analysis in statistics. The new guide (soon to be published as E3159) develops many of the commonly reoccurring reliability metrics and related topics found in many industrial quarters and specifies methods for use in reliability calculations. ASTM International member Stephen Luko,…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Katerina Koperna, tel +1.610.832.9728 kkoperna@astm.org Release #10573
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A proposed ASTM International standard aims to promote a shared understanding of the science and engineering behind pharmaceutical freeze-drying. The proposed standard ( WK63507 ) is being developed by ASTM’s committee on the manufacture of pharmaceutical and biopharmaceutical products ( E55 ). According to ASTM member Arnab Ganguly, uncertainty over the best practices in these areas of freeze-…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #10571