InTouch
January / February 2018

Building Community - ISPE Guidance Documents

Konyika Nealy, MPH, DHSc
Article - ISPE Pharmaceutical Engineering

ISPE was a publishing powerhouse in 2017, producing 10 documents that reflect new titles and refreshed content. Each was made possible by a group of talented professionals, both staff and members, who harnessed laser-focused determination to put current, practical information into your hands.

SUCCESSES

The Risk-MaPP guide was well received by both industry and regulators for its focus on shared facilities and health-based exposure limits. It also included a special acknowledgement to the EMA’s Health-Based Exposure Limit Guide EU Implementation Team for their valued review and contributions. Another highlight was the GAMP® Guide: Records and Data Integrity, published at the end of March, which sold over 1,000 copies in just over six months.

What does that tell us? ISPE provided what the industry needed, when it needed it—and the industry noticed.

CHALLENGES

ISPE’s Publications Department lost some familiar faces in 2017, and some momentum along with them. But we rallied and were soon back on track. New folks like me and our technical editor Nina Wang found ourselves in a flurry of activity. Coming from industry ourselves, we were energized by the conversations in our Communities of Practice around changing regulations, reducing risk, and leveraging scarce resources. The question was how to share that dynamic thinking and problem-solving ability more broadly with our members. And thus, the work of planning for 2018 began.

WHAT’S NEXT?

The new year will build on the successes of 2017. We’ll continue to streamline processes and incorporate new technology to drive ISPE forward. Long-awaited revisions to the Baseline® Guides for commissioning and qualification and sterile product manufacturing facilities are coming in 2018. Several new Good Practice Guides (GPGs) covering process validation, single-use technologies, HVAC and process equipment filters, asset management, and equipment reliability
will also debut.

Because our membership survey revealed that Guidance Documents are ISPE’s most valued asset, we’ve made access to all ISPE GPGs (25 titles) free to members. Members now have unlimited access via our new online publishing portal. Online communities will also be refreshed with new features and content.

“Because our membership survey revealed that guidance documents are ISPE's most valued asset, we’ve made access to all ISPE GPGs (25 titles) free to members”

GUIDANCE DOCUMENTS PUBLISHED IN 2017

  • GAMP® Guide: Records and Data Integrity
  • GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems
  • GAMP Good Practice Guide: Global Information Systems (GIS) Control and Compliance (Second Edition)
  • GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)
  • Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition)
  • ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

YOUR ROLE

What can you do to help? First, join one or more of our CoPs if you have not already done so (ispe.org/communities-practice). You’ll have access to information, tools, and best of all, a connection to your peers to exchange ideas and find solutions to everyday problems. Next, join a writing team. We have several technical guides and papers in development and your expertise is always welcome. Finally, if you see that there’s question that is not being addressed in our library, submit a proposal and let’s work together to find some answers.

With a new year comes new challenges and goals. There’s a lot to do to outpace last year. I would like to thank each of you for your continuous support, enthusiasm, and dedication—we couldn’t do this without you.