The Pharmaceutical Quality Assurance module is designed to provide trainees knowledge of applied pharmaceutical sciences, Chemical and Regulatory affairs. Novel concepts in leading edge industrial pharmaceutical research, Quality Assurance and Compliance are a major component of the module.
This course provides an overview of the pharmaceutical industry, including basic information about MHRA requirements and approval processes, the role of key operational units in QA/QC, drug manufacturing processes, Production record and Batch record. This course enables the trainees to: understand the role of the pharmaceutical industry in the global market and its implication.
The course includes a background in pharmaceutical sciences and introduces new concepts in pharmaceutical quality control, statistics, regulatory affairs and GMP. A crucial component of the foundation module is the introduction of pharmaceutical ethics and law, which prepares trainees for dealing with drug regulatory issues and compliance .
The Pharmaceutical Quality Assurance & Quality Control programme combines theoretical knowledge with hands-on skills in all areas that impact drug quality. Practical experience is gained in pharmaceutical quality control, Batch record review and processes, technical writing skills, regulatory compliance and proper documentation procedures. Some of the skills obtained during the programme include:
- Documentation systems
- Drug stability studies
- Quality and compliance auditing
- Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
