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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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Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.

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A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.

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