The "new" GAMP (Good Automated Manufacturing Practices), the "gospel" for those who develop and validate computerized systems intended for use in the Life-Science industry (Pharmaceutical, Biotech, Medical Devices, Nutritionals, etc.) have been published in 2022 (the previous edition was from 2005) and the volume of over 400 pages including text, appendices and glossaries has the subtitle "A Risk-Based Approach to Compliant GxP Computerized Systems".
As stated in the incipit, the Guide, created by the Gamp working group of ISPE (the international association that brings together professionals in the Life Science industry), aims to be of support to companies in the sectors regulated by the GxP (the guidelines for the development, production and distribution of drugs): it is not a regulatory document, it is not a "de Jure" standard and it is not automatic that systems developed in accordance with the Gamp are accepted by the supervisory and control authorities in pharmaceutical sector, which operate according to protocols shared at a supranational level. We remind you that for regulations you need to refer in Italy to the Italian Medicines Agency, while the supervisory body of the European Union is the European Medicines Agency (EMA). Instead, the US Food and Drug Administration (FDA) operates in the United States and for all plants that intend to export products to the United States.
However, it is undeniable that the GAMPs are a "de facto" industrial standard to which all participants in the supply chain in the pharmaceutical industry comply, from machinery and plant manufacturers, to producers and suppliers of raw materials, semi-finished products, active ingredients, complementary and packaging products, consultants and service providers for the life science industry and of course all drug manufacturers and packers operating in countries subject to stringent industry regulations.
In the preface of this second edition of GAMP5, which deliberately did not switch to GAMP6 numbering precisely to give continuity of vision, it should be noted that the recent period of the global pandemic of Codid-19 has underlined the essential role of new technologies for the protection of public health: in particular this GAMP5 guide tends to promote its use precisely to safeguard product quality and patient safety.
Innovations are essential for the life science industry to increase value for the whole society, controlling costs and reducing time-to-market.
The extensive regulation of this industrial sector could lead to adopting approaches that are too rigid to comply with the standards, which are often not commensurate with the actual risk for product quality and patient health: in this view, the revision of the GAMP5 proposes innovation for risk assessment and an efficient and effective use of resources also by applying new approaches in the development of systems and the use of market technologies.
Read the white paper "Gamp5 (2nd Edition) and the Security” edited by Enzo M Tieghi, Mario Testino and Andrea Falcone. During the 62nd AFI Symposium (7-8-9 June 2023) it will be possible to see the presentation poster.
Index
- Introduction
- Security in GAMP5
- Key Requirements for Security Management.
- Organizational controls for the management of Security
- The Information Security Management System (ISMS)
- Physical and Technological Checks
- Incident monitoring and management
- CLOUD environments
- AUDIT
- Management review
- GxP compliance and security patches
- Security Certification Programs
- Security reference matrix in GAMP5 Second Edition
- Appendix: Data integrity and non-compliance in the pharmaceutical industry