Special interest groups (SIGs) have been an important part of ISPE for many years. Special Interest Groups are formed around a specific area of interest, policy, or technology in which members have identified a common challenge. These “microcommunities” foster interaction among a variety of technical domains and often result in creative responses to industry change. Special Interest Groups must align with a community of practice (CoP) steering committee or the Knowledge Network Council.
Special Interest Groups are excellent forums for exchanging ideas and best practices, problem-solving with other experts, and staying informed about new developments in specialized topics. Over the years, several Special Interest Groups have contributed valuable resources to ISPE: papers, articles, blog posts, Guidance Documents, and conference sessions.
One notable Special Interest Group project is the education session on current good manufacturing practices and out-sourcing facilities (Section 503B of the FD&C Act∗) presented by the Compounding Pharmacies Special Interest Group at the 2016 ISPE Annual Meeting & Expo. Although small in number, this Special Interest Group was nimble enough to deliver timely programming on a hot topic. The group remains focused on sharing ISPE’s knowledge to improve the quality of personalized medicine and efficiency of the drug supply chain. Organized by the Sterile Products Processing CoP, the Compounding Pharmacies Special Interest Group is seeking new members from other interested CoPs.
The Serialization Special Interest Group was created in response to the DSCSA† product identifier requirement with members from the Packaging, Operations Management, Project Management, and GAMP® CoPs. This Special Interest Group spearheaded ISPE’s comments on the US Food and Drug Administration’s (FDA) “Grand- fathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier” draft guidance and the 2017 ISPE Pharmaceutical Serialization workshops. The Serialization Special Interest Group is seeking members to help develop white papers and other planned projects.
The GAMP® Cloud Special Interest Group authored a series of concept papers that were published in 2016:
- “ SaaS in a Regulated Environment: The Impact of Multi-Tenancy and Subcontracting”
- “ Using SaaS in a Regulated Environment: A Life Cycle Approach to Risk Management”
- “ Evolution of the Cloud: A Risk-Based Perspective on Leveraging PaaS within a Regulated Life Sciences Company”
The GAMP® Data Integrity Special Interest Group, the most prolific of the groups, authored the blog posts “Data Quality and Data Integrity: What Is the Difference?” and “Considerations for a Corporate Data Integrity Program,” as well as the 2017 best-selling GAMP Records and Data Integrity Guide. The group has delivered training at multiple conferences and chapter events, and has Gericke Continuous Feeding- Mixing-Modules supply mixtures already begun to author a subsequent series of Data Integrity Good Practice Guides.
SIG membership is open to all active ISPE members in all geographic areas. If you’d like to learn more or if you’re interested in joining a SIG, email us at communities@ispe.org.
ISPE Special Interest Groups
- Compounding Pharmacies
- GAMP® Agile
- GAMP® Blockchain
- GAMP® Cloud
- GAMP® Data Integrity
- GAMP® Manufacturing Executions Systems
- Serialization
* The Federal Food, Drug, and Cosmetic Act (FD&C Act), enacted in 1938, authorized the FDA to oversee the safety of food, drugs, and cosmetics. Section 503B identifies the bulk drug substances that can be used in compounding. (FDA.gov)
† Enacted in 2013, the Drug Supply Chain Security Act (DSCSA) outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs. (FDA.gov)
