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Content of an Audit Trail / Must an Audit Trail be printable?

The requirements for an audit trail can now be found almost everywhere in the relevant pharmaceutical regulations. Six experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Questions 1 and 2: From an inspector's perspective, what are the minimum requirements for the content of an audit trail and must an audit trail be printable?

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USP: Chapter <1029> Good Documentation Guidelines and Data Integrity published for comment

The chapter "<1029> Good Documentation Guidelines and Data Integrity" has been published for comment on the website of the USP Pharmacopeial Forum since the beginning of July 2025. Comments and remarks on this draft, which is based on the previous version "<1029> Good Documentation Guidelines" from May 2018, can be submitted until September 30, 2025.

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Data Integrity & IT Compliance Group Developments January through April 2025

Find out what the ECA Data Integrity & IT Compliance Group was working on and accomplished in the first four months of 2025 - in the latest report.

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How does FDA train and guide its Inspectors?

The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators. Although primarily used internally by FDA staff, it is available publicly. The Manual has now been revised.

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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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Data Integrity Violations at an OTC Manufacturer

During an inspection, the US FDA found significant violations in the area of data integrity and documentation at a manufacturer of OTC drugs in Thailand. The violations identified relate to incomplete laboratory data, manipulated records and inadequate control of electronic systems.

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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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