White Paper
Manufacturing Drugs with Highly Potent APIs
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In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs), including:
- a review of the relevant guidance
- HPAPI classification systems
- safety processes to minimize exposure risk
- equipment and methods to prevent cross-contamination
- how to ensure GMP compliance for regulatory submissions
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