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ISPE E-Letters
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.
Current E-Letters: April 2012
Critical Utilities (CU)
Potential Savings Using the Updated ISPE Water and Steam Guide
A presentation by an author of the newly released ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition) provides an overview of why the original guide was revised, the revisions (including new content), and potential water/energy/cost savings that may be realized through modern industry practices discussed in the Guide. More.
Engineering Standards Benchmarking
How Does the Industry Align Corporate Engineering Standards, Industry Guidelines, and Regulatory Requirements?
ISPE’s ESB community conducted a GMP Design (Quality) Survey to find out. The results were presented in an 8 March live webinar by Francesca McBride, Director of Regulatory Compliance for Jacobs and Co-Chair of the ESB COP. The webinar, recorded and available for purchase, presented tools the pharmaceutical industry uses to document and align corporate engineering standards and industry guidelines with international regulatory requirements. Also covered is the impact these documents have on design review, qualification, and validation and how to identify which GMP, EHS, and other regulations apply and why. More.
Heating, Ventilation, and Air Conditioning (HVAC)
Task Team to Address HVAC Energy Reduction in Life Science Facilities
ISPE’s HVAC and Sustainable Facilities communities have formed the Energy and Environment Task Team to address HVAC energy reduction opportunities in life science facilities. The team plans to develop content addressing the problem statement: Actual and perceived internal and external compliance barriers prevent significant reduction of energy consumption in life science facilities. For more information and to support this task team, visit the HVAC COP and Sustainable Facilities COP websites. More.
Investigational Products (IP)
Use of Booklet Labels on Investigational Medicinal Products (IMPs)
A concept paper by the ISPE COP Booklet Label Task Team reflects on results of a study site survey, draws conclusions from an assessment on comparison of Booklet Labels versus Single Panel Labels performed, discusses benefits of a Good Practice Guide, and defines the need for training on the proper use of booklet labels. More.
Operations Management
Simulations for Improved Production Cycles Using a Lean Supply Chain Postponement Strategy
A supply chain postponement strategy is a valuable lean design concept for the biopharmaceutical industry that has applicability particularly because of the typical multi-stage production processes involved in the conversion of raw materials through to final customer fulfillment. An article discusses a case study focusing on postponement as a supply chain strategy and how to develop the design process and the benefit of using simulation to test a new design, including one such as postponement, prior to implementing it in practice. More.
Packaging
Share Your Knowledge of Innovative Drug Delivery and Packaging in Pharmaceutical Engineering
The Packaging COP is seeking Subject Matter Experts to help write technical articles addressing hot topics for the September/October 2012 issue of Pharmaceutical Engineering. This issue will include articles that feature fill and finish operations and a myriad of the evolving needs of product packaging. Innovative drug delivery systems, involving new processes, new equipment, and green packaging concepts, in addition to packaging operations of the future could be explored in detail. Articles focusing on serialization matters, packaging safety, machines and controls integration, and related labeling needs could be possible features. More.
Process Analytical Technology (PAT)
Concept Paper Calls for Better QbD Knowledge Management
The Data Management Task Team of ISPE’s PAT community published the Concept Paper, “Implementing Knowledge Management in Bioprocesses: A QbD Driven Approach Turning Data into Knowledge in Reference to the CMC A-Mab Case Study.” The paper discusses information and knowledge management implementation in a QbD environment based on a CMC A-Mab Case Study. The aim of the paper is to analyze gaps in state-of-the-art QbD strategies for data and knowledge management, suggest solutions, and demonstrate potential benefits for improved quality and economy. 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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