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The US FDA recently published a further Warning Letter to a Chinese manufacturer, which has joined the growing list of companies that have established no or inadequate quality control units due to the lack of testing and control of raw materials used.

The International Coalition of Medicines Regulatory Authorities (ICMRA) launched the "Collaborative Hybrid Inspection Pilot (CHIP)" in 2021. Now a report has been published summarising key findings and proposing next steps.

In a Warning Letter to a manufacturer of non-sterile drugs, the FDA criticized, among other deficiencies, a lack of testing of the manufactured batches for microbiological quality in accordance with USP chapters <61> and <62>, which deal with the "Enumeration" test and the test for "Specified Microorganisms".

The GMP/GDP Inspectors Working Group decided at the end of 2023 to extend the validity of GDP and GMP certificates that expired at the end of the year until 2024 or until the next on-site inspection, whichever occurs first. It has now been clarified that from 2025, this extension no longer applies.