ESB COP Resources

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These resources are just one of the many benefits of being an ESB COP Member.
Join the ESB COP and ask questions in the community discussions and gain solutions to real-world problems.  Also, share your experience and expertise by responding to inquiries.

Note that only ISPE Members can engage in these activities.  If you are not an ISPE Member, join ISPE and take advantage of all the benefits that membership has to offer.

  • Decommissioning Survey Results ( 1 MB)
    The 2013 Decommissioning Survey benchmarks decommissioning programs that industry uses for facilities and equipment. The focus of the Decommissioning Survey is to better understand what standards are in-place to govern decommissioning programs, define the scope of the decommissioning program and identify the different aspects or components of the program.
  • Freeze Dryer Survey Results ( 1 MB)
    A 2012 survey by ISPE’s Sterile Products Processing (SPP) and Engineering Standards Benchmarking (ESB) 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.
  • Engineering Standards Program Survey Results ( 1 MB)
    The goal of the survey conducted in 2012 is to provide benchmarking data to the ISPE community regarding the existence and application of Engineering Standards across the industry.
  • Security Standards Survey Results ( 1 MB)
    These results are to from a 2012 survey addressing security-related standards. The goal of the survey is to improve our overall security through benchmarking.
  • cGMP Design Quality Brief Survey Results ( 509 KB)
    The ESB COP Steering Committee developed a survey to evaluate the methods used by the pharmaceutical industry for the identification and communication of the applicable requirements during the early phases of projects. The survey was prepared and executed by active members of the ESB COP Steering Committee in June/July 2011 and included representatives from the drug manufacturers and engineering/construction and validation service providers.
  • Architectural Survey Results ( 694 KB)
    The survey was prepared and executed by active members of the ESB COP Steering Committee in 2011 and included representatives from the drug manufacturers and engineering/construction and validation service providers. The following summarizes the survey questions and the responses provided by the ESB COP.
  • ESB COP Survey Results July 2009 ( 742 KB)
    This represents the discussion by the steering team regarding the collected data this summer and should spur ongoing discussion on the topics for benchmarking.  Please use them to stimulate the Community Discussions.

 


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