This course provides an introduction to GMP for pharmaceuticals and the current U.S. FDA regulations. It reviews a brief history of GMP regulations and discusses the regulatory requirements for the quality management system, equipment, batch records, validation, packaging, labeling, holding, distribution, and audits.
There are many components to the GMP regulations, and this course provides a general introduction to many of these key elements. This course reviews manufacturing regulations 21 CFR 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Drugs) and 21 CFR 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals 2021). It also discusses FDA guidance and applicable question and answer (Q&A) documents intended to assist industry.
Language Availability: English
Suggested Audiences: Distribution Staff, Labeling Staff, Other sponsor organization representatives that contract to GMP vendors and need to understand the regulations., Packaging Staff, Production and Manufacturing Technicians, Quality Professionals, Validation Staff
Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person