DESIGN OF EXPERIMENT, STATISTICAL THINKING AND PROCESS CONTROL IN PHARMACEUTICS AND BIOTECHNOLOGY
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- Versione italiana
- Academic year
- 2015/2016
- Teacher
- DIMITRIOS REKKAS
- Credits
- 6
- Didactic period
- Primo Semestre
- SSD
- CHIM/09
Training objectives
- The course, under the above mentioned general title, aims at introducing the students to the major scientific fields of Statistical Thinking and Knowledge Management, Statistical Experimental Design and Quality by Design. This will eventually make the students capable (main learning outcome) of applying the experimental design principles and the statistical process control tools to characterize and optimize processes either at the lab scale or higher, such as the manufacturing of pharmaceutical and biotechnological products.
To this extent modern manufacturing approaches such as the lean and agile production methods are presented. In addition, as the Pharmaceutical and Biotechnological Industry is regulated through a number of guidelines, which intend to assure the quality of their products with respect to their safety and efficacy for the end user, i.e., the patient, these are presented in detail together the discussion in class of many real life examples.
The main acquired knowledge will be:
- deep understanding of the concept of quality by design (QbD)
- knowledge of the statistical tools for QbD implementation at the development phase of pharmaceutical and biotech products
- knowledge of the scientific basis of pharmaceutical/biotech guidelines
The basic acquired abilities (that are the capacity of applying the acquired knowledge) will be:
- ability to use the statistical process control tools like the control charts to monitor the process performance
- ability to understand the concept of the related regulatory guidelines for risk management, quality systems, quality metrics, corrective and preventive actions and continuous process verification.
All the above are also developed with examples from pharmaceutical dosage forms such as injectables and the production of orally dissolving delivery systems. In other words, the theoretical part is always connected to case studies. Prerequisites
- The subjects of the first 3 years of the Pharmacy curriculum are considered as pre-requisites, in particular Pharmaceutical Technology and basic statistics. 4th year students can follow the lectures without problems. When needed, explanations and clarifications are provided on site either at the end or during the same lesson.
Course programme
- The theory of quality - Quality by Design.
Knowledge and Risk management - Statistical thinking.
Systems theory and the Pharmaceutical quality system - Quality Metrics - Corrective and Preventive actions - Continuous process verification.
Design of experiments - Statistical process control tools - Control Charts.
Lean thinking and manufacturing - Sterile products and clean rooms - Orally dissolving dosage forms and fixed dose combination products.
Case studies such as the practical applications of experimental design, the Failure Mode and effect Analysis (FMEA) and the Fault Tree Analysis (FTA) as risk management tools. Didactic methods
- Lectures and case studies by means of Power Point slides. All lectures are given in English.
The lectures are adjusted to meet the basic knowledge of the students. A session of questions and answers (Q&A) is implemented right after each lecture to facilitate discussion and reveal the points that need clarifications. Moreover a step by step approach is implemented in several topics to make sure that the students can follow the flow of the lectures. This method improves student participation and can reveal their interest in learning new approaches and quality improvement methods based on scientific thinking.
The way of teaching is flexible, when possible, in the sense that some of the case studies can be adjusted almost on site to subjects that the students are studying in other courses at the same time. An example is the adoption of the Pharmacovigilance as a subject for applying the risk management tools, as the students participate in a compulsory course on Pharmacovigilance taking place during the same teaching period.
Finally, a special review session has been organized at the end of the teaching period where the students can raise questions on several topics and generate a discussion to clarify further any particular point. Learning assessment procedures
- Written examination at the end of the courses.
The students are asked to answer to 30 questions, requiring short but precise answers, covering the contents of the lectures taught during this period.
Examination language is English. Reference texts
- A series of few carefully selected articles is suggested, for providing the students with reference reading material and assist them in studying for the exams:
“Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals”, E. Korakianiti, D.M. Rekkas, Pharmaceutical Research, (2011) 28: 1465–1479.
“The Evolution of the Manufacturing Science and the Pharmaceutical Industry”, S.N. Politis, D.M. Rekkas, Pharmaceutical Research, (2011) 28: 1779–1781.
Per the students’ request more references are delivered during the course to cover their personal educational development.
