EC-New Zealand MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification
Titel:
EC-New Zealand MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification
Herkunft/Verlag:
EG Kommission
Inhalt:
The provisions of this Sectoral Annex cover all medicinal products which are industrially
manufactured in New Zealand and the European Community, and to which Good
Manufacturing Practice (GMP) requirements apply.
For medicinal products covered by this Sectoral Annex, each Party will recognise the
conclusions of inspections of manufacturers carried out by the relevant inspection
services of the other Party and the relevant manufacturing authorisations or licences
granted by the Competent Authorities of the other Party.
In addition, the manufacturer’s certification of the conformity of each batch to its
specifications will be recognised by the other Party without re-control at import.
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