Prêtable
| Titre : | Good manufacturing practices for pharmaceuticals |
| Titre original: | Bonnes pratiques de fabrication pour les produits pharmaceutiques |
| Auteurs : | Graham P Bunn, Editeur scientifique |
| Type de document : | texte imprimé |
| Mention d'édition : | Seventh edition |
| Editeur : | New york [U.S.A.] : CRC press, 2019 |
| ISBN/ISSN/EAN : | 978-1-4987-3206-2 |
| Format : | 1 vol. (xiii-371 p.) / 25 cm |
| Langues: | Anglais |
| Langues originales: | Anglais |
| Index. décimale : | 615.19 (Chimie pharmaceutique) |
| Catégories : | |
| Mots-clés: | Pharmaceutical industry ; Drugs ; Industrie pharmaceutique |
| Résumé : |
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
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| Note de contenu : |
Sommaire :
Chapitre 1: Status and Applicability of U.S. Regulations: CGMP Chapitre 2: Quality Management Systems and Risk Management Chapitre 3: Management Responsibility and Control Chapitre 4: Organization and Personnel Chapitre 5: Finished Pharmaceuticals: General Provisions Chapitre 6: Production and Process Controls Chapitre 7: Records and Reports Chapitre 8: Clinical Trial Supplies Chapitre 9: Contracting and Outsourcing Chapitre 10: Buildings and Facilities Chapitre 11: Equipment Chapitre 12: Control of Components and Drug Product Containers and Closures Chapitre 13: Holding and Distribution Chapitre 14: Returned and Salvaged Drug Products Chapitre 15: Active Pharmaceutical Ingredients Chapitre 16: Pharmaceutical Excipient Good Manufacturing Practices Chapitre 17: Packaging and Labeling Control Chapitre 18: Laboratory Controls Chapitre 19: Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy Chapitre 20: CGMP Enforcement Alternatives in the United States Chapitre 21: FDA Inspection Process Chapitre 22: FDA Pre-approval Inspections Chapitre 23: Worldwide Good Manufacturing Practices Chapitre 24: Data Integrity and Fundamental Responsibilities |
Exemplaires (1)
| Cote | Support | Localisation | Section | Disponibilité |
|---|---|---|---|---|
| F8/11794 | Livre+Format PDF | Bibliothèque de la Faculté de Technologie | Salle des livres | Disponible |
