The FDA's current views on cGMP compliance for Phase I investigational drugs and biological products
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Because certain requirements in 21 CFR part 211, which implements § 501(a)(2)(B) of the FD&C Act, addressed the commercial manufacture of products typically characterized by large, repetitive, commercial batch production (e.g., those relate to the validation of manufacturing processes (§ 211.110(a)) and storage (§ 211.142)), they may not be suitable for the manufacture of most investigational medicinal products used for Phase 1 clinical trials.
The FDA has issued regulations for IND products to protect human subjects participating in clinical trials. For example, 21 CFR part 312 requires sponsors to submit chemical, manufacturing, and control (CMC) information about a drug or biological product as part of an IND application (§ 312.23(a)(7)).
For more information contact –
Organization: NetZealous BDA GlobalCompliancePanel
Website: http://www.globalcompliancepanel.com/
Email: [email protected]
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