GMP News

Since the end of April 2022, the second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" is available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adaptations in Appendices 2 and 3. Appendix 5 has been newly added.

The U.S. Food and Drug Administration (FDA) has published a new version (Revision 1) of its Guidance for Industry on Out-of-Specification (OOS) Results. The original version of the document was published almost 16 years ago, in October 2006.

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.

To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.

The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.

During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of general chapter 5.21. Chemometric methods applied to analytical data to be published in Ph. Eur. Supplement 11.1 and be effective as of 01 April 2023.

The area of responsibility of the Responsible Person for Good Distribution Practice is quite extensive. Therefore, the question arises which tasks actually have to be performed personally and which duties can be delegated.

On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?

Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.

The FDA Office of Pharmaceutical Quality has published its annual report for 2021. What does the report say on its eleven pages?

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.