Ateneo - UPO

The course will cover the key aspects of quality assurance of cosmetic and dermatological products: quality assessment during product development (Quality by Design approach); implementation of stability tests of active pharmaceutical ingredients (API) and finished products according to international regulatory guidelines (ICH); principles of qualitative and quantitative analysis for determining the identity and purity of APIs and their potency in the finished products.

Students will be provided with the slides projected during lessons. Original scientific articles, useful for understanding the topics covered during the course, will also be provided.

Quality control (QC) of pharmaceuticals involves a series of rigorous processes and testing procedures to ensure that products meet specified standards and regulatory requirements. By attending the course, the student will be able to manage the theoretical and practical aspects of quality control in pharmaceutical products from the raw materials to the finished product and the most common analytical techniques involved.

Frontal lessons and discussion of case studies. Laboratory activities.

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities
Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

Written test covering the material delivered in the lessons and seminar (true/false questions and open questions) + evaluation of the QC laboratory report.

• Pharmaceutical Quality System and implementation of Quality by Design: an overview; • Drug stability testing: regulatory guidance (ICH) and accepted industry practices; • Validation of analytical procedures; • Discussion of case studies: development and validation of a stability indicating HPLC method for stability testing of topical formulations; • Training to Quality Control Laboratory; • Seminar hold by an external teacher “Quality Assurance and Good Manufacturing Practices for Cosmetic industry”.

At the end of the course, which also includes laboratory activities, the student will have knowledge of the key aspects of quality assurance of cosmetic and dermatological products. They will also have knowledge of the analytical procedures used to determine the purity of the active pharmaceutical ingredients and their potency in the corresponding formulations. Furthermore, the student will be able to calculate, interpret and evaluate the analytical data obtained.