[Testing of vaccines. The challenge of testing complex combination vaccines]. / Prüfung von Impfstoffen. Die Herausforderung der Prüfung komplexer Kombinationsimpfstoffe.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
; 57(10): 1188-92, 2014 Oct.
Article
en De
| MEDLINE
| ID: mdl-25204275
Vaccines are biologicals. This group of medicinal products is produced with a predefined variability based on the biological starting materials used. Vaccines are subject to official control authority batch release performed by the Paul-Ehrlich-Institut (PEI). To release batches to the market, experimental testing has to be conducted by an official medicines control laboratory as the PEI. It is the aim of this independent testing to demonstrate the conformity of quality criteria with conditions set in the marketing authorization for each lot produced. The testing is performed on the basis of vaccine specific batch release guideline and due to the difficult and time consuming testing procedures often run in parallel with manufacturers testing. If test results comply with the predefined criteria, the lot in question is released. This article describes the challenge of official control authority batch release testing of two complex combination vaccines.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
/
Vacunas
/
Evaluación de Medicamentos
/
Laboratorios
Tipo de estudio:
Guideline
/
Prognostic_studies
País/Región como asunto:
Europa
Idioma:
De
Revista:
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
Asunto de la revista:
SAUDE PUBLICA
Año:
2014
Tipo del documento:
Article
Pais de publicación:
Alemania