A UL EduNeering course
US Food and Drug Administration-regulated products—food, drugs, biologics, and medical devices—must be created using current good manufacturing practices (cGMPs). Specifically, active pharmaceutical ingredients (APIs) need to be made in accordance with cGMPs. Unlike for medical products, there are no specific US regulations for APIs (although some have been proposed). Until API-specific regulations are finalized, this course reviews how cGMPs can be applied to the manufacture of APIs.
- cGMP requirements for active pharmaceutical ingredient (API) manufacturing personnel
- GMP requirements for building and facilities
- cGMP requirements for manufacturing equipment
- Requirements for materials and packaging components
- Process controls for APIs
- Laboratory controls for APIs
- Record-keeping requirements
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields