ESB COP E-Letters

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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 real world problems.

*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.

January 2013

ESB COP Analyzes Results of Security Standards Survey
In March of 2010, a break in of a pharmaceutical warehouse resulted in theft of over $75 million worth of product. The boldness and size of the theft sent shockwaves throughout the industry. In response, the Engineering Standards Benchmarking Community of Practice (ESB COP) agreed to sponsor a survey on the topic of Security Standards. More. ( Adobe PDF 267 KB)

Survey Benchmarks Industry Engineering Standards Programs
The ESB COP Steering Committee conducted a survey on Engineering Standards Programs in October 2012. The goal of the survey was to provide benchmarking data to the ISPE community regarding the existence and application of Engineering Standards across the industry and compare the data to a similar survey conducted in 2009 to identify trends. More. ( Adobe PDF 491 KB)

New ESB Surveys Planned for 2013
Already the groundwork had been laid for the next two surveys to be conducted in the 1st Q 2013. The first will focus on Decommissioning, and the second on Periodic Evaluation/Qualification (PEQ). More.

July 2012

Survey Says: Most See Benefits of Vacuum Hold Tests for Lyophilization
A survey by ISPE’s Engineering Standards Benchmarking (ESB) and Sterile Products Processing (SPP) communities indicate that most people involved in the use of lyophilization for sterile products manufacturing see the benefits of using Vacuum Hold Tests as part of the overall control strategy for the process. More.

A Snapshot of ESB COP Surveys
Since 2008, the ESB COP Steering Committee has led the development of a number of surveys focused on benchmarking industry practices on the development, maintenance, and processes for handling variances with internal engineering standards. More.

Contribute to Your Society – Be Part of the Engineering Standards Benchmarking Steering and Task Teams
The ESB COP was founded in 2008 by industry professionals responsible for engineering standards at their company, with the objective of providing a forum for the discussion on key topics and industry practices on the development, maintenance, and processes for handling variances with internal engineering standards. The ESB COP Steering Committee is actively seeking individuals to make an impact in the industry by volunteering time and expertise in the development and analysis of benchmarking surveys planned for the remainder of 2012.

Visit the ISPE Volunteer Resource Center and scroll down to the Engineering Standards Benchmarking (ESB) COP section for information on other ESB COP volunteer opportunities.

April 2012

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.

Coming Soon: More Benchmarking Surveys
The ESB COP is planning several surveys during the coming months, including surveys on Standards Programs, Security Standard, Decommissioning of Systems, Periodic Review/Evaluation of Systems, Maintenance of Equipment and Systems, and Equipment Design. Volunteer opportunities are available for those interested in participating in survey development and the data analysis process. More. ( Adobe PDF 13 KB)

Contribute to Your Society – Be Part of the Engineering Standards Benchmarking Steering and Task Teams
The ESB COP Steering Committee is actively looking for individuals to make an impact in the industry by volunteering time and expertise in the development and analysis of benchmarking surveys planned for 2012. To know more about the different opportunities, please visit the ISPE Volunteer Resource Center.

October 2011

Results of Architecture Survey Now Available
Results of a survey by the ISPE Engineering Standards Benchmarking (ESB) Community of Practice (COP) to evaluate architectural finish practices by the pharmaceutical industry are now available. More.

Results of GMP Design (Quality) Survey Now Available
The ESB COP has made available the results of a survey to evaluate methods used by the pharmaceutical industry for the identification and communication of the applicable cGMP and quality requirements during the early phases of projects. More.

Volunteer Opportunities with the ESB Community
The Engineering Standards Benchmarking (ESB) COP has several volunteer opportunities. Projects include participating in the Logistics Task Team, Survey Data Analysis Task Team, and Education Program Committee. More.

Coming Soon: Webinar on Results of GMP Design (Quality) Survey
The ESB COP is planning a Webinar for December 2011 to discuss in greater detail the results of their GMP Design (Quality) Survey. The survey evaluated methods used by the pharmaceutical industry for the identification and communication of the applicable cGMP and quality requirements during the early phases of projects. Exact date and information coming soon.

January 2011

Report Summarizes Results of Engineering Standards Enforcement Survey
The Engineering Standards Benchmarking (ESB) Community of Practice (COP) Steering Committee developed a survey to evaluate the methods used by the pharmaceutical industry in the internal enforcement of their engineering standards. A report summarizes the survey questions and the responses provided by the ESB COP. Read more ( Adobe PDF 39 KB).

ESB COP Volunteer Opportunities
The ESB COP is seeking volunteers for both its Survey Data Analysis and Benchmarking Task Teams. Read more.

What the ESB Community is Discussing Right Now
Does your company provide formal training on Engineering Standards, Guidelines, Specifications and/or Practices to their Project Teams? How do you control your drawings? Your colleagues would like to hear your thoughts on these and other topics under the Community Discussions section at the ESB Community of Practice site. Read more.

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