E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs) . The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions. To read the E-Letters, follow the links below. You can gain access to information on that particular topic, additional headlines on emerging trends and key issues in that COP, and much more.
*COPs are now an ISPE Member-only benefit, therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing all E-Letter content and other valuable resources that will assist you in being more effective at your job.
ISPE Biotech Conference Explores Next Generation Manufacturing
Discover how engineers will develop and validate projects using next-generation manufacturing systems, advances in bioprocessing, and streamlined compliance programs. The ISPE Biotechnology Conference (27 – 28 August 2013 in Durham, North Carolina, USA) will feature a plenary session with Nobel Laureate Dr. Oliver Smithies and opportunities to interact with biomanufacturing experts on process development, facility design and integration, compliance and process validation, and many other topics. More.
Critical Utilities (CU)
New Elemental Impurity Limits in Pharmaceutical Waters
Recently, and in concert with other pharmacopoeias and regulatory bodies, the United States Pharmacopeia (USP) adopted plans for the implementation of limits on specific elemental impurities, typically metals, in pharmaceutical ingredients and products. An article by Anthony Bevilacqua and Teri C. Soli discusses the four metals (analytes) considered most toxic, and having the lowest permissible dosage levels, and whether the current specifications for WFI or Sterile Water will comply with these elemental impurity specifications. More.
Engineering Standards Benchmarking (ESB)
Survey Results Give Insight into Industry Decommissioning Programs
The ESB Community of Practice released results of a survey benchmarking decommissioning programs that the pharmaceutical industry uses for facilities and equipment. The results give insight into current standards, scope, aspects, or components of decommissioning programs. More.
Investigational Products (IP)
ISPE Patient Initiative Issues Survey Related to Patient Experience with Clinical Trial Materials
ISPE is conducting a global survey on patient experiences with clinical trial materials. The survey is designed to obtain feedback on areas such as the suitability of clinical trial packaging, label information and design, interacting with clinical trial technologies, and transportation and storage. With a target of 2000 or more patients from around the world, this study is the first known of its kind in size and scope. More.
PMMI and ISPE Partner to Launch Pharma EXPO
PMMI, owner and producer of the PACK EXPO trade shows, and ISPE announced the debut of Pharma EXPO, a new event designed to connect pharmaceutical, medical device and nutraceutical manufacturers with the packaging, processing and other supply chain technologies they need to meet rigorous industry regulations and grow business. The event will debut in 2014 and co-locate with PACK EXPO International (November 2-5, 2014; McCormick Place, Chicago). More.
Don't see an E-Letter relevant to your interests?
ISPE has 19 Communities of Practice, many of which have, or are in the process of generating an E-Letter. Visit any Community of Practice to access more E-Letters and numerous other resources. ISPE's Communities of Practice (COPs) enable like-minded professionals to connect through an interactive online community. Through professional networking and peer collaboration, ISPE's COPs produce discipline-specific content that deepens members' knowledge and expertise, increases quality and continuous improvement in the industry, and help to achieve ISPE's core purpose of leading global innovation.
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