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CGMP Summary

September 16, 2022
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CGMP IN A NUTSHELL Know what you are supposed to do before you do it. Document everything that occurs. According to the FDA, “if it isn’t documented, it didn’t happen.” …

Code of Federal Regulations

September 16, 2022
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CODE OF FEDERAL REGULATIONS (CFR) The Code of Federal Regulations (CFR) is comprised of the general and permanent rules of the federal government. The CFR contains the official text of …

Drug Development Overview

September 16, 2022
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THE DRUG DEVELOPMENT PROCESS The complexity of drug development has greatly increased over the past 40 years. The process requires a preclinical phase of drug development, an investigational new drug …

CGMP Review

September 16, 2022
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Current Good Manufacturing Practices (CGMP) Current Good Manufacturing Practices are a system for ensuring that regulated healthcare products, such as drugs and medical devices, are consistently produced and controlled according to …