Technical / White Paper
Manufacturing Drugs with Highly Potent APIs
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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