Chemistry Review

Each review division employs a team of chemists responsible for reviewing the chemistry and manufacturing control sections of drug applications. In general terms, chemistry reviewers address issues related to drug identity, manufacturing control, and analysis. The reviewing chemist evaluates the manufacturing and processing procedures for a drug to ensure that the compound is adequately reproducible and stable. If the drug is either unstable or not reproducible, then the validity of any clinical testing would be undermined because one would not know what was really being used in the patients, and, more importantly, the studies may pose significant risks to participants.

At the beginning of the Chemistry and Manufacturing section, the drug sponsor should state whether it believes the chemistry of either the drug substance or the drug product, or the manufacturing of either the drug substance or the drug product, present any signals of potential human risk. If so, these signals should be discussed, with steps proposed to monitor for such risks.

In addition, sponsors should describe any chemistry and manufacturing differences between the drug product proposed for clinical use and the drug product used in the animal toxicology trials that formed the basis for the sponsor's conclusion that it was safe to proceed with the proposed clinical study. How these differences might affect the safety profile of the drug product should be discussed. If there are no differences in the products, that should be stated.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.