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GMP News

14.01.2026

Data Integrity & IT Compliance Group Developments September through December 2025

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

14.01.2026

Could a change of ownership be relevant to GMP?

The subject line asks whether a change in the ownership of a pharmaceutical manufacturer could affect GMP compliance. According to the FDA, the answer is yes.

14.01.2026

Testing for ethylene glycol, diethylene glycol and methanol – a hot topic during FDA inspections

As can be seen from the quotations in FDA warning letters over the past three financial years, violations relating to the testing of raw materials and high-risk components are a recurring theme among GMP deficiencies at manufacturers of topical products and hand sanitisers. This led to the publication of two important FDA guidance documents two years ago.

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