title: [Testing of vaccines. The challenge of testing complex combination vaccines].
abstract: 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.
authors.affiliation: Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
authors.forename: A
authors.initials: A
authors.lastname: Merkle
authors.forename: H
authors.initials: H
authors.lastname: Lechner
authors.forename: V
authors.initials: V
authors.lastname: Oppling
authors.forename: H
authors.initials: H
authors.lastname: Meyer
mesh_terms: D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000592:standards; D005858:Germany; D017408:Guidelines as Topic; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014612:Vaccines / Q000032:analysis* / Q000592:standards*
chemical_list: D014612:Vaccines