 | Study programme 2019-2020 | Français | |
| GMP-GLP-Validation | |||
Learning Activity |
| Code | Lecturer(s) | Associate Lecturer(s) | Subsitute Lecturer(s) et other(s) | Establishment |
|---|---|---|---|---|
| M-DOYM-012 |
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|
| Language of instruction | Language of assessment | HT(*) | HTPE(*) | HTPS(*) | HR(*) | HD(*) | Term |
|---|---|---|---|---|---|---|---|
| Français | Français | 15 | 0 | 0 | 0 | 0 | Q1 |
| Description of the modifications to the Q3 2019-2020 online assessment procedures (Covid-19) |
|---|
| Written test (multiple choice questions + open-ended questions) via the Moodle Exam platform |
Content of Learning Activity
Role of the different industrial departments (Production, Quality Control, Research & Development (R&D), Quality Assurance(QA) + objectives of the regulatory authorities that check the implementation of the quality standards. Basic principles of good manufacturing practices + main differences between GMP and GLP. The focus will be set on the Good Documentation Practices (GDP), the analytical method validation and the equipment qualification.
Required Learning Resources/Tools
A pdf copy of the Powerpoint slides presented during the lectures will be available for download onto the Moodle platform
Recommended Learning Resources/Tools
Sans objet
Other Recommended Reading
[1] ICH Q2: Validation of Analytical Procedures: Test and Methodology; CPMP/ICH/381/95 guideline. [2] Guide de Validation des Méthodes en Biologie Médicale;Cofrac, Document LAB GTA04, Révision 00- Juin 2004. [3] Guidance for Industry : Bioanalytical Method Validation;, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001.
Mode of delivery
- Face to face
Type of Teaching Activity/Activities
- Cours magistraux
- Conférences
Evaluations
The assessment methods of the Learning Activity (AA) are specified in the course description of the corresponding Educational Component (UE)