 | Study programme 2020-2021 | 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 |
|---|---|---|---|---|---|---|---|
| Anglais | Anglais | 15 | 0 | 0 | 0 | 0 | Q1 |
| Organisational online arrangements for the end of Q3 2020-2021 assessments (Covid-19) |
|---|
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| Description of the modifications to the Q3 2020-2021 assessment procedures (Covid-19) |
| Written test (multiple choice questions + open-ended questions) in person or via the Moodle Exam platform if it's necessary.because of the sanitary conditions. |
Organisational arrangements for the end of Q1 2020-2021 assessments (Covid-19) online or face-to-face (according to assessment schedule)
- Written exam (multiple choice, open questions)
Description of the modifications to the Q1 2020-2021 online assessment procedures (Covid-19) online or face-to-face (according to assessment schedule)
Written test (multiple choice questions + open-ended questions) in person or via the Moodle Exam platform if it's necessary.because of the sanitary conditions.
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)