GMP News - Quality Assurance

The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.

The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. FDA recently issued revised versions of two previously published draft guidances.

The FDA posted several Warning Letters to companies illegally selling cannabidiol products intended for use in food-producing animals due to safety concerns. The agency is taking these steps to protect animals and the safety of the food supply chain.

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Is it allowed to verify the authenticity of the UI when the product is not in physical possession?

The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in the first chapter, such as actions related to the management of the COVID 19 pandemic, work related to the scientific evaluation of medicinal products and their monitoring.

Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.