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Cloud Computing: Audit / Remote audit of a Cloud Service Provider

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 11: How many days must be planned for the audit of a CSP? Is it also possible to carry out a remote audit?

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Cloud Computing: Which Persons should participate in the Audit of a CSP and which Topics should be addressed?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 10: Which persons (functions) should participate in the audit of a CSP and which topics should (must) be addressed?

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Cloud Computing: Multi-tenant provisions of SAAS and Change Control

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 9: The multi-tenant provision of SAAS is accompanied by a source code basis for all customers. This implies that all customers must have the same software version irrespective of whether or not a customer accepts a certain change. Is this compatible with GxP?

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Cloud Computing: Which contents must be covered by the service provider's change control?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 8: Which contents must be covered by the service provider's change control and in which way must the contract giver be integrated into this system?

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Cloud Computing: QMS of the Cloud Service Provider (CSP)

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 7: Can we assume that if there is an appropriate QMS implemented and if the CSP acts in compliance with this QMS (as a result of an audit), the service provided functions in accordance with the specification and the operational controls are carried as described in the CSP's internal procedures?

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Review of GAMP®5 Second Edition

At the end of July 2022 ISPE published an updated version of the widely accepted GAMP®5 guidance on 'A Risk-Based Approach to Compliant GxP Computerised Systems'. Read a first short review about the content of the revised version here.

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Cloud Computing: Common Certifications (e.g. ISO 27000 ff) and their Role in GxP

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 6: Are common certifications (e.g., 27000ff) reliable evidence that a cloud service provider is suitable, or what requirements must a certification fulfill in order for it to play a role in the suitability of a CSP?

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Cloud Computing: Legal basis for cloud solution in a GxP environment

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas: Question 5: The AMWHV (Arzneimittel- und Wirkstoff-Herstellungs-Verordnung) requires that all data according to the manufacturer's authorization reside on the premises. Is then a cloud solution possible at all?

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Cloud Computing: Are SaaS closed systems per 21 CFR Part 11?

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas: Question 4: Are SaaS closed systems per 21 CFR Part 11?

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FDA Warning Letter caused by Lab Data Integrity issues

In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022. Significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs) are listed and a long list of Data Integrity remedation activies is required.

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