QUALITY ASSURANCE :PRINCIPLES AND APPLICATIONS IN THE PHARMACEUTICAL FIELD
Academic year and teacher
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- Versione italiana
- Academic year
- 2022/2023
- Teacher
- CATIA CONTADO
- Credits
- 6
- Didactic period
- Secondo Semestre
- SSD
- CHIM/01
Training objectives
- This introductory course provides an overview of key drug quality concepts, standards, regulations, and practices in non-clinical development and manufacturing for the pharmaceutical industries.
Students will learn the roles of quality assurance (QA), quality control (QC), and the chemistry, manufacturing, and control (CMC) drug development process in ensuring the safety, efficacy, and quality of drug products. It covers industry-standard processes such as SOPs, system and method qualification/validation and certificates of analysis (COA).
Students should be able of:
- describing the quality assurance and control processes;
- using the acquired knowledge to analyse an hypothetical case of drug production (example)
- proposing an improving strategy for the drug production. Prerequisites
- Students shoud also have a good attitude for the legal language.
Students should have a good preparation in analytical chemistry (students should know quite well the most common analytical techniques in use in the pharmacutical labs, e.g. HPLC, HPLC-MS) and pharmaceutical technologies. Course programme
- The concept of Quality Assurance in the pharmaceutical industry.
National, European and International regulations
Introduction to the quality systems in the pharmaceutical production Good Practice (GP): GLP, GMP, GCP
ISO 9000 and ICH Q8, Q9, Q10 document.
Quality by Design
Quality Risk Management
Design of experiments (DoE)
Personal and organization
Internal and External Quality Audit
Quality control (CQ)
Documentation
Standard Operating Procedures (SOPs)
Analytical methods validation and Analytical Transfer
Deviations
Steps for deviation managing
Tools to study the deviation
Deviation monitoring
Supporting documentation
Non-Conformity management and CAPA (Corrective Action and Preventive Action)
To define the CAPA
Role and positive aspects of CAPA in the QS
Monitoring of CAPA
Supporting documentation
Seminars by experts of the QA field, working in pharmaceutical and/or cosmetic firms. Didactic methods
- The educational approach foresees to give frontal lessons along with tutorial moments.
Seminars, given by experts of pharmaceutical industries, will also proposed. Learning assessment procedures
- Students will be evaluated with an oral interview of 30-40 minutes. The questions will randomly pick topics faced during the lessons.
The test will be public and graded according to the content and the appropriateness of the used language. Reference texts
- European directives are available on-line from websites that will be suggested during the lessons, while some of the Quality Control contents are available in many book of analytical chemistry or chemiometry.
At the end of the course, the teacher will provide a pdf copy of what discussed in the classroom.
Example of useful books:
Piotr Konieczka, Jacek Namiesnik - Quality Assurance and Quality Control in the Analytical Chemical Laboratory: A Practical Approach - 2nd Edition, CRC Press, 2018, 280 Pages. ISBN 9781138196728.
Eamonn Mullins - Statistics for the Quality Control Chemistry Laboratory - Royal Society of Chemistry, 2003, ISBN: 0854046712,9780854046713
L. Fabris & A. Rigamonti - La fabbricazione industriale dei medicinali - Esculapio 2008, ISBN: 978-88-7488-242-7
