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GMP News

Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1

During the ECA Live Online Training "Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation" on 29 April 2024, many interesting aspects were discussed in the Q&A session. We have compiled a selection of the questions with the teaching team's answers. You can read Part 1 here.

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Serialization - Version 21 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. The new version contains four new Q&As compared, which mainly cover the tasks of parallel traders when dealing with safety features during repackaging. 

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FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a contract testing laboratory in Uruguay. The inspection revealed significant CGMP violations, specifically related to the laboratory data integrity and documentation practices. Key issues included incomplete laboratory records, unreviewed out-of-specification (OOS) results, and lack of controls over electronic data and manual integrations.

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