Audit of the Production of Sterile Medicines for Compliance with the Requirements of the Draft EU GMP Annex 1 with Risk Analysis

DOI

10.2991/isils-19.2019.36How to use a DOI?

Keywords

annex 1; aseptic production; PIC/S; risk analysis; inspection

Abstract

The role of the PIC/S organization in the pharmaceutical industry was noted, the main aspects and place of inspection activities in the production of medicines were determined, the general classification of incompliances, as well as the main methods and tools for risk assessment were considered. An object of research is the operating production of sterile medicines and internal documentation of the site. In the course of the experimental part of the work, an audit of the operating manufacturing of sterile medicines was carried out included the following main steps: 1. Preparation for the audit of the production site [Comparison of the current version of Appendix No. 1 of the Rules of Good Manufacturing Practice of the Russian Federation (Order of the Ministry of Industry and Trade of the Russian Federation of June 14, 2013 No. 916 of the Ed. December 18, 2015 “On Approval of Rules of Good Manufacturing Practice”) and draft Appendix No. 1 EU GMP (EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products)], developing an audit plan and protocol, assessment system; 2. Audit of the site and filling in the audit report; 3. Evaluation of the audit protocol, taking into account risk analysis. Risk analysis was performed using FMEA method; 4. Development of recommendations to eliminate incompliance and the formation of a report based on risk analysis.

Copyright

© 2019, the Authors. Published by Atlantis Press.

Open Access

This is an open access article distributed under the CC BY-NC license (http://creativecommons.org/licenses/by-nc/4.0/).

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TY  - CONF
AU  - Artemii Kodash
AU  - Anna Basevich
AU  - Tatiana Bitkina
AU  - Elena Smirnova
AU  - Irina Kaukhova
PY  - 2019/11
DA  - 2019/11
TI  - Audit of the Production of Sterile Medicines for Compliance with the Requirements of the Draft EU GMP Annex 1 with Risk Analysis
BT  - Proceedings of the 1st International Symposium Innovations in Life Sciences (ISILS 2019)
PB  - Atlantis Press
SP  - 255
EP  - 257
SN  - 2468-5747
UR  - https://doi.org/10.2991/isils-19.2019.36
DO  - 10.2991/isils-19.2019.36
ID  - Kodash2019/11
ER  -