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The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter due to CGMP violations related to combination products. Key violations include inadequate controls to ensure the sterility of drug products, deficient dissolution testing, and a lack of process validation.

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The United States Food and Drug Administration has issued a Warning Letter to a Chinese manufacturer. The violations include inadequate raw material testing and insufficient stability testing programs.

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With the draft chapter <1110>, the USP completes its programme with recommendations on the subject of contamination control strategy, as already called for in other documents.

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A manufacturer of OTC products from Mesquite, Texas received a Warning Letter from the US FDA for deficiencies in various areas ranging from microbiology and raw material analysis to cleaning and disinfection.

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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.

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In a recent GMP news, we pointed out deficiencies, especially regarding stability data, of an Indian manufacturer by referencing an FDA Warning Letter. This Warning Letter also offers interesting interpretation aids on the subject of cleaning validation. What is the FDA interested in?

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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.

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After inadequate Root Cause Analyses were repeatedly the subject of FDA Warning Letters, a 'Statement of Non-Compliance with GMP' has now also been published in EudraGMDP. And another Warning Letter.

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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".

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In 2022, the WHO published the "Technical Report Series 1044, 2022" called "TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing" on the subject of technology transfer.

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