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Registration dossier of chemical active substance

Krystyna Gryz 

Urzad Rejestracji PLWMiPB, Zabkowska 41, Warszawa 03-736, Poland

Abstract

During the registration process quality of medicinal products is assessed on the basis of chemical documentation of active substance and chemical, pharmaceutical and biological documentation of finished product.

In the European Union a common format of documentation – CTD (Common Technical Document) is applicable for every the type of regulatory procedure (centralized procedure CP, decentralized procedure DCP mutual recognition procedure MRP and national procedure NP).

Data concerning quality of medicinal product are included in Module 3.2.S and must contain the following information:

3.2.S.1 General Information

3.2.S.2 Manufacture

3.2.S.3 Characterisation

3.2.S.4 Control of Drug Substance

3.2.S.5 Reference Standards or Materials

3.2.S.6 Container Closure System

3.2.S.7 Stability

There are three possible ways for submission of documentation of quality of the active substance:

· Active Substance Master File (ASMF)

· Certificate of Suitability of the Monographs of the European Pharmacopoeia

· Module 3.2.S

European legislation requires manufacturing of every active substance according to GMP.

 

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Related papers

Presentation: Oral at VI Multidyscyplinarna Konferencja Nauki o Leku, by Krystyna Gryz
See On-line Journal of VI Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2008-03-21 19:23
Revised:   2009-06-07 00:48