Cloud Computing: Are (GMP) Supervisory Authorities allowed to inspect CSP?

The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also organizational advantages speak for the cloud. At the same time, however, potential dangers and regulatory restrictions should also be taken into account. Nine experts from the pharmaceutical industry and regulatory authorities answer a comprehensive catalog of questions from the following GxP-relevant topics:

• Basics of Cloud Computing Technology
• Regulations and Expectations of Inspectors
• Customer-Supplier-Relationship
• Requirements for Cloud Service Providers (CSP)
• Requirements for Supplier Evaluation and Supplier Audits
• Requirements for Qualification / Validation

The following question is one of a series of questions that we will publish in further GMP News articles on this site in the coming weeks.

Question 21: Are (GMP) supervisory authorities allowed to inspect CSP? If not, is this planned for the future? - Regulations and Expectations of Inspectors

According to AMG § 64 (1) No. 6 (Arzneimittelgesetz - (Medicinal Product Act) German law based on European regulations/directives), establishments and enterprices are subject to supervision by the competent authorities where records are kept that relate to manufacturing, testing, storage, packaging, distribution, etc. This includes paper archives outside the establishment.
The legislator had in mind paper archives outside the premises and documentation on tissue donations in facilities such as hospitals, but the wording of the law also includes the electronic archiving of the corresponding data, as this is generally permitted in accordance with the AMWHV  (Arzneimittel- und Wirkstoffherstellungs-Verordnung - German law) and EU GMP guidelines.
In principle, the AMG requires clarification in some areas with regard to the handling of electronic data, as well as the processes of digitization and automation in the manufacture and testing of medicinal products.

Find more Q&As on the topic "Cloud Computing" which have been answered by the expert team.

The Experts

Frank Behnisch, CSL Behring GmbH, Marburg
Klaus Feuerhelm, Formerly Local GMP Inspectorate / Regierungspräsidium Tübingen
Oliver Herrmann; Q-FINITY Quality Management, Dillingen
Eberhard Kwiatkowski, PharmAdvantageIT GmbH, Neuschoo
Stefan Münch, Körber Pharma Consulting, Karlsruhe
Yves Samson, Kereon AG, Basel
Dr. Wolfgang Schumacher, Formerly F. Hoffmann-La Roche AG, Basel
Dr. Arno Terhechte, Local GMP Inspecorate / Bezirksregierung Münster
Sieghard Wagner, Chemgineering Germany GmbH, Stuttgart