Start-UP Companies, Compliance, GMP, Regulatory

Understanding cGMPs for Phase 1 Investigational Drugs

July 18, 2019 ||
 
Everyone in the pharmaceutical manufacturing industry understands or has at least heard of current Good Manufacturing Practices (cGMP).  The requirements of the cGMPs are prescribed in Title 21 of the Code of Federal Regulations parts 210 and 211 (better known as 21 CFR part 210 and 211).  But there is…
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“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”

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