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As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.

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With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.

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Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.

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An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.

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The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

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Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.

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In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.

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The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.

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The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.

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Stability studies of pharmaceuticals are a well-established discipline and, of course, an important regulatory requirement. Nevertheless, an evaluation of the last two fiscal years shows that deficiencies in the stability program are mentioned in numerous FDA 483s.

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