The Pharmaceutical Quality & Regulation PG Diploma combines specialist good manufacturing practices (GMP) and analysis knowledge with an understanding of local and global legislation in order to produce quality professionals who can provide long-term solutions to critical manufacturing defects and are able to work in production planning and inventory control, method development and validation, quality risk management and regulatory roles such as development and assessment of clinical trial dossiers in a pharmaceutical industry.
The course teaches you to be able to apply a range of academic content and principles needed in pharmaceutical manufacture. You will obtain and demonstrate a range of transferable and problem-solving skills allied to the course content, making graduates highly suited to a career in the pharmaceutical industry in areas associated with manufacturing, quality assurance and regulation.
The UCL School of Pharmacy hosts several well-established medicine-oriented research centres and is equipped with up-to-date facilities and equipment required for the manufacture and analysis of pharmaceutical products. Students benefit from “hands-on” learning within the School of Pharmacy and extensive links to UK pharmaceutical and biotechnology industries, phase I clinical research centres, and UK and EU regulatory agencies.
The programme consists of four modules (30 credits each), which can be completed over ONE calendar year (but you may, with the agreement of the course director, choose to take the modules over several years up to a maximum of five). Each module will be divided into three blocks (refer to course overview guide). Blocks will be delivered by attendance at UCL each month. There will be a short assessment at the end of each block, which will allow you to monitor your progress.
In the Pharmaceutical Manufacture module (October to December), you will learn about pre-formulation studies and product development, major pharmaceutical processing technologies, critical quality control parameters, packaging principles and storage, and distribution of materials and finished products. This is a foundation module that will provide the basis of the whole programme. You will be exposed to latest developments in relevant technologies including quality by design (QBD). This module will be taught in three (3) blocks: (i) Sterile manufacture (ii) Non-sterile manufacture and (iii) Pharmaceutical microbiology.
In the Pharmaceutical Analysis module (January to March), you will learn about important analytical and testing techniques including separation and spectroscopic techniques used in identification and quantification of active pharmaceutical ingredient as well as finished pharmaceutical products. You will also study effective “out of specification” (OOS) investigation strategies. You will be exposed to and apply important statistical tests including process control charts, capability index (Cp) and CpK used in sampling, shelf-life calculation and stability determinations of pharmaceutical raw materials and finished products. This module will be taught in three (3) blocks: (i) Active Pharmaceutical Ingredients (APIs), (ii) Pharmaceutical analysis and testing, and (iii) Pharmaceutical statistics.
In the Quality Assurance module (April to June), you will study the principles of quality assurance. The module covers principles of Pharmaceutical Quality Systems (PQS), procedures, processes and control measures in pharmaceutical packaging and Investigational Medicinal Products (IMP). You will learn the principles involved in the design and conduct of clinical trials. Furthermore, you will learn about Issue management including: Root cause analysis (RCA), Managing corrective actions and preventive actions (CAPA), Managing deviations and recall of medicinal products. This module will be taught in three (3) blocks: (i) Pharmaceutical quality systems, (ii) Pharmaceutical packaging, and (iii) Investigational Medicinal Products (IMPs).
In the Regulatory Affairs module (July to September), you will study pharmaceutical legislation. You will learn about local (UK), European (EU/EEA) and international legislation and guidance applicable to the manufacture, import and distribution of pharmaceutical products with special reference to the European Economic Area (EEA). In addition, you will learn about the differences between directives and regulations and their significance. You will learn how to conduct internal and external audits with reference to sourcing of raw materials from within and outside the EU. You will also learn about key concepts within medicinal chemistry, toxicology and therapeutics and their importance in manufacturing and controlling the quality of medicinal products. This module will be taught in three (3) blocks: (i) Law and administration, (ii) EU GMP and (iii) Medicinal chemistry, toxicology and therapeutics.
2nd October 2019
Application submission deadline
31st August 2019
Course Director: Dr Khalid Sheikh