GMP NEWS 2023

The FDA issued the final guidance on verification systems under the DSCSA. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify the FDA if needed.

FDA's Center for Drug Evaluation and Research (CDER) announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. The CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approaches in drug development programs.

In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2023. As in previous years, we have again performed an evaluation with regard to deficiencies in the stability programme.

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 14: What should the assessment of "cloud suppliers" include from an authority's point of view?

The Competent Authority of Germany (Regierungspraesidium Freiburg) has entered a new GDP non-compliance report into the EudraGMDP database. The list of deficiencies identified is quite long and the deviations run through almost all chapters of the EU GDP Guidelines.

The Competent Authority of Czechia (State Institute For Drug Control) has entered a new GDP Non-Compliance Report into the EudraGMDP database. A wholesale distributor seriously violated the GDP requirements by failing authorized storage facilities.

GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport and storage of the active pharmaceutical ingredients (APIs) used for production. But what general requirements actually apply to the GDP-compliant storage of APIs for medicinal products for human use or veterinary medicinal products?

Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany)  has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide.