PIC/S Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
Titel:
PIC/S Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
Kurztitel:
PI 021-2
Herkunft/Verlag:
Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Inhalt:
The scope of this document is to set at the inspectors’ disposal, a working instrument to increase the performance in GMP inspections performed at a site that manufactures, packages and/ or labels medicinal products for clinical trials used on human subjects.
GMP Seminare nach Thema
- Allgemeine QA Themen + GMP Compliance
- Regulatory Affairs
- Development
- Datenintegrität
- Analytik allgemein
- Good Distribution Practice
- Computervalidierung
- Validierung allgemein
- Pharma Engineering allgemein
- API/Wirkststoffe/Hilfsstoffe
- Medizinprodukte und Combination Products
- GMP Grundlagen / Basis-Seminare
- Verpackung und Packmittel
- Hygiene
- Biotechnologie/Blut/ATMP
- Sachkundige Person (QP)
- European Conferences and Education Courses
- Sonstiges
- GMP Audits
- Dokumentation
- Reinigungsvalidierung
- IT allgemein
- Verunreinigungen/Impurities
- OOS / OOT / OOE
- Rohstoff-Prüfung
- Methodenvalidierung
- Gerätequalifizierung
- Stabilitätsprüfung
- Allgemeine mikrobiologische Themen
- Mikrobiologische Tests
- Technik
- Herstellung allgemein
- Sterile Herstellung
- Feste/halbfeste Formen
- Phytopharmaka/Cannabis/Radiopharmazeutika