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Welcome to E-Letters
E-Letters are topic-specific, electronic newsletters delivered via email.
E-Letters address your needs as a professional in the pharmaceutical industry based on your specific areas of interest. The content for E-Letters is submitted by like-minded practitioners in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions. We are confident the information will prove valuable.
Your link to technical and regulatory information relevant to your areas of interest. Stay on the pulse of emerging trends and key issues in your discipline by accessing these and other resources generated by ISPE's global Communities of Practice (COPs).
Current E-Letters: April, 2009
Containment
Brazil's ANVISA to Revise GMPs, Address Cross Contamination
Brazil's National Health Surveillance Agency (ANVISA) is revising its Good Manufacturing Practices for Medications. Recently released, the revisions include a section on production practices for the prevention of bacterial and cross contamination. Read more.
Investigational Products (IP)
Implementation of CT Directive: Update from Belgium
Two guidance documents ("Circulars 527 and 528") were released by the Belgian MOH (AFMPS/FAGG) December 2008. Those guidances have an impact on both the clinical trial applications (definition of errors/missing documents that are considered as "showstoppers" by the competent authorities to start the review of the CTA, labeling requirements, specific format required for the QP declaration) and the importation of CT materials in Belgium (new forms to be used to declare importation of IMP in Belgium). Read more.
Oral Solid Dosage (OSD)
Introducing ISPE's New Oral Solid Dosage (OSD) COP
This new Community of Practice (COP) is the exchange for all aspects associated with pharmaceutical oral solid dosage. View webinars and engage in or create online discussions tackling contract manufacturing, generics manufacturing, and changes in processing equipment and continuous processing development. Read more.
Sterile Products Processing (SPP)
Top 5 Citations from US FDA Sterile Drug Inspections
What were the top five citations from US FDA Sterile Drug Inspections in 2008? These and other findings from the FDA are included in a presentation by Tara Gooen delivered at the ISPE Tampa Conference in March. Read more.
Sustainable Facilities
Lessons Learned in Sustainability from Award-Winning Project
A presentation by Con Leddy of the PM Group looks at lessons learned, sustainability achievements, and sustainable energy engineering from Centocor Biologics Ireland's BioCork project, Category Winner of the 2009 Facility of the Year Award for Sustainability. Read more.
Don't see information relevant to your discipline? ISPE has 18 Communities of Practice, many of which have, or are in the process of generating an E-Letter. Visit any Community of Practice site to access more E-Letters and numerous other resources.
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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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