A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing operation. This course will introduce participants to the essential features of a US Good Manufacturing Practice (GMP)-compliant quality management system as well as covering recent developments in pharmaceutical regulation. The duties of personnel in the production, quality control and quality assurance departments will be explained, together with requirements for GMP-compliant documentation and records. The expectations of regulators regarding the qualifications, experience and on-going training/development of personnel will also be covered.
Special emphasis will be given to the relatively recent topic of pharmaceutical data integrity, including controls required over quality-critical electronic data systems. Participants will also be introduced to the concept and application of quality risk management in a GMP environment.