World of Compliance Module

FAQ

1. Why are current good manufacturing practices (cGMPs) required?
   1. cGMPs ensure that drug products are not adulterated. When doing development work, a firm needs to make sure that it is following all of the rules and regulations, and ensure reproducibility and comparability of its products once they are on the market.
2. Are certificates of analysis enough to guarantee the quality of inactive ingredients?
   1. Because people have died based on good certificate analysis, we are trying to make industry -- in this country and internationally - aware that they need to know the provenance of the products that they are selling. It's not always the active ingredient; excipients are just as important.
3. When an investigation reveals severe deviations, FDA can take regulatory action including an injunction for closure. Is the firm permanently closed?
   1. No. It can produce again. If FDA believes that the health of the public is at imminent risk, it enjoins the firm from manufacturing. This can be stopping the manufacturing of a single product, several products, a class of products or the entire firm. FDA provides evidence to a judge indicating that there is a problem and asks the judge to grant an injunction.