Review of Post-registration Changes in the Life Cycle of Сholera Bivalent Chemical Vaccine (Review)

Abstract

Introduction. The inevitable of post-registration variations due to the improvement of production processes and quality control related to the integration of the modern technological solutions, replacement of equipment, suppliers of raw, consumables and packaging materials, improvement of form release or composition, administrative changes, as well as obtaining new data on clinical efficacy and safety of immunobiological medicinal products (IMP) during post-marketing studies.Text. The purpose of this work is to analyze the post-registration changes in the life cycle of IMP «Сholera bivalent chemical Vaccine» produced by Russian State anti-plague Research Institute «Microbe», reflecting the harmonization of the documents of the registration dossier with the innovations of the Russian legislation, the optimization of production and quality control. First of all, the changes made to the registration documentation for IMP concerned the updating of the dossier in accordance with the adopted Federal laws and Resolutions of the government of the Russian Federation. The following changes related to the optimization of methods for controlling the limit content of impurities of substances used at different stages of antigen production. Also, the changes were associated with the improvement of consumer properties of the drug, namely the introduction of modern polymer packaging and several drug’s form release, convenient for use in practical health care institutions. The latest change of Pharmacopoeia enterprise article (PEA) R N001465/01-111119 regulates the application of identification means in the form of a two-dimensional bar code (QR-code) on the packaging of medicines, which is due to compliance with the requirements of article 67 «Information on medicines. The system of monitoring the movement of medicines» Federal law N 61 «Оn medicines circulation».Conclusion. Maintaining the required level of quality of IMP when changing production technology or control requires a comprehensive analysis of the proposed changes in order to make them in the documents of the registration dossier. At the same time harmonization of documents of the registration dossier with novelties of the Russian legislation is a necessary condition for implementation of production activity within the legal field.

Keywords

• registration dossier
• pharmacopoeia monograph
• cholera bivalent chemical vaccine
• post-registration changes