The results of a survey of 39 Notified Bodies were published by the EU Commission at the end of 2023. It concerns certifications and applications under the Medical Device/IVD Regulations (MDR/IVDR). What are the results?
Statistics are also necessary in the field of medical devices. In the USA, there is even a separate paragraph in the FDA's Quality System Regulations (QSR, 21 CFR 820). In 21 CFR 820.250, statistical techniques are also required with regard to sampling plans. A current Warning Letter clearly shows this.
The U.S. Food and Drug Administration (FDA) has released a draft guidance document that provides comprehensive guidance on conducting use-related risk analyses (URRAs) for drugs, biological products, and combination products.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. The company failed to conduct necessary quality testing on their drug products, including testing for active ingredients and raw materials. Additionally, there were issues related to process validation, equipment cleaning, and facility maintenance.
The USP Packaging and Distribution Expert Committee proposes to revise the two USP glass chapters <660> Containers - Glass and <1660> Evaluation of the Inner Surface Durability of Glass Containers. The revision includes the addition of new glass materials.
In August, the final guideline ICH E11A Guideline on pediatric extrapolation was published on the ICH website in the efficacy guidelines section. It is seen as a supplement to the guideline ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION E11 (R1) and is due to come into force in January 2025.
After inadequate root cause analyses had already been the subject of a Warning Letter from the FDA in mid-August, another one was published just a few days later. This time for a company in the US.
The EDQM published the second edition of the Technical Guide on Metals and Alloys.
Warning Letters from the US FDA provide an interesting guide to interpreting the FDA's CGMP regulations. A current Warning Letter shows interesting considerations of the FDA regarding the tasks of quality assurance. What does the FDA think?
Pharmaceutical cleanrooms are extremely vulnerable in the event of a leak in the cleanroom ceiling area. Water ingress, e.g. due to leaking pipes, operating errors, e.g. with hoses or rain ingress via the building roof, is relatively common. The number of possible individual risks is very high. But what should the first and medium-term measures be?