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Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

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The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

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Since the beginning of the pandemic and the associated travel restrictions, the FDA has been hesitant to decide whether to conduct distant assessments. Now, more and more criticism is spreading.

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The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic.

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EMA has published a Guidance document, providing points for consideration relating to Distant Assessments.

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A look at the warning letters to pharmaceutical companies of the last nine months of the current fiscal year (Oct. 2019 - June 2020) shows the most frequent GMP violations found by FDA inspectors. Read more about the Warning Letter Analysis in this article of the GMP Journal

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Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.

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Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.

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The updated version of the paperback "ICH Q7 Side-by-Side Comparison", which lists and compares the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" on GMPs for APIs, is now available.

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