Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.

US FDA investigators' increased focus on aseptic operations is resulting in more Form 483 observations of microbiological contamination issues over the past few years.

One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”

High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.

High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.

Manufacturers should expect that remote audits of suppliers may take longer than onsite ones until they get more familiar with these audits; it is also important to abide by data confidentiality rules and take frequent breaks when conducting these audits, says Rx-360 CEO.