FDA's current thinking on cGMP compliance for Phase I Investigational Drug and Biologic products

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Because certain requirements in 21 CFR part 211, which implement § 501(a)(2)(B) of the FD&C Act, were directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production (e.g., those regulations that address validation of manufacturing processes (§ 211.110(a)), and warehousing (§ 211.142)), they may not be appropriate to the manufacture of most investigational drugs used for phase 1 clinical trials.

FDA has issued regulations governing IND products to protect human subjects enrolled in clinical trials. For example, in 21 CFR part 312, sponsors must submit chemistry, manufacturing and control (CMC) information on a drug or biological product as part of an IND application (§ 312.23(a)(7)).

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Organization: NetZealous BDA GlobalCompliancePanel

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  1. GlobalCompliance Panel
  2. 21 CFR part 211
  3. 21 CFR part 312
  4. manufacturing and control (CMC) information
  5. understanding of the cGMP strategie
  6. Phase I Investigational Drug and Biologic products
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Wow, what a dry presentation, absolutely no effort to embellish or describe anything! A perfect example would have bee to give some examples of that does not need to do but would need to be done on future batches. I get the impression that this guy does not know himself, we can read the slides, what is he for?

flynnpaul