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FDA Warning Letter on missing Audit Trails and Raw Data Review

Among other things, the lack of verification of the electronic raw data and the audit trail led to a warning letter to a south african company. What did the FDA criticise?

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14 Submissions for the Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology 2025

The Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology will once again be presented at the PharmaCongress on 8 and 9 April in Wiesbaden. This year, 14 projects have applied for the award, with topics ranging from optimised technology to AI applications.

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New FDA-Guidance for Industry draft on AI

AI (Artificial Intelligence) is becoming an increasingly important topic in the pharmaceutical sector. On 7 January 2025, the FDA published a first draft of a Guidance for Industry 'Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products'. The comment period ends on 7 April 2025. What is the FDA's focus here?

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FDA Warning Letter caused by insufficient Documentation Practices

In February 2025, the U.S. FDA issued a Warning Letter to the Indian company "Tyche Industries Ltd" due to insufficient Documentation Practices.

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APIC: Update of Data Integrity FAQs

In January 2025, the Task Force "Data Integrity" of the Quality Group of APIC, a sector group of the European Chemical Industry Council (CEFIC), published version 2 of the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. Updated and new questions and answers can be found in the "Password management" and "Access management" sections.

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First GDP Non-Compliance Report of 2025: Data Integrity Issues at Hungarian Wholesaler

The competent authority of Hungary has issued a new GDP Non-Compliance Report in the EudraGMDP database. The report mentions two critical observations: data integrity problems and unauthorized personnel performing critical decisions regarding medicinal products.

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Cloud Computing: Documents for a smooth migration to the cloud

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 25: What documents are required for the Pharmaceutical Entrepreneur to plan for a smooth migration to the cloud?

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Cloud Computing: Open or Closed System according to 21 CFR Part 11?

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 24: If the pharmaceutical user has data in the cloud, what type of system is it? Is this an open or closed system according to 21 CFR Part 11?

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Cloud Computing: Validation documents for a SaaS application

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 23: What validation documents are required for a SaaS application? Who provides which documents?

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Cloud Computing: What happens if the CSP does not allow audits?

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 22: The information on the Quality System and on audits concerning suppliers or developers of software and systems used should be made available to inspectors on request. What happens if the CSP does not allow audits? What alternatives to an audit would be accepted?

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