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Team leads for this project have requested assistance from SME's participating in the following Communities of Practice groups in reviewing the draft ISPE Baseline Guide: Sterile Manufacturing Facilities 4th Ed:
• Advanced Therapy Medicinal Products (ATMPs)
• Biotechnology
• Commissioning & Qualification
• Critical Utilities
• Pharmaceutical Compounding
• Process/Product Development
• Sterile Products Processing
• Sustainable Facilities, HVAC & Controlled Environments
The deadline for volunteer participation is 1700 EDT, Tuesday, 10 February 2026.
For questions, please contact Guides@ispe.org.
Your participation is crucial if you possess expertise in these areas and are interested in reviewing the technical content of the draft ISPE Guidance Document.
Participant Information: Any ISPE members with technical expertise in this area are welcome to participate, and we encourage global participation. Before expressing your interest, ensure familiarity with the ISPE Guidance Document's topic and a commitment to providing feedback on the technical content.
If you choose to volunteer, you will receive a link to view the draft in PDF format, an MS Excel comment form, and review instructions when the draft is ready.
Please note: Volunteers will have three weeks to review the draft and submit comments. A specific review deadline will be provided with the draft document and comment form.
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