GDP Non-Compliance Report: Procurement from Non-Qualified Suppliers
In August 2022, the National Agency for Medicines and Medical Devices of Romania added a new GDP Non-Compliance Report to the EudraGMDP database. The company in question "failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities)".
Shortages and Crisis Preparedness: EMA Publishes List of the Main Therapeutic Groups of Medicinal Products
The EMA has published a list of the main therapeutic groups in order to avoid shortages of medicinal products in the case of a public health emergency and thus to ensure the supply of critical medicinal products. Another EMA document defines the methodology for establishing and maintaining this list and further lists of critical medicinal products.
Deficiencies in the quality system repeatedly lead to so-called GPD Non-Compliance Reports. But what are the requirements for the quality system in the GDP environment, and which processes must be in place within the company?
GDP in the US: New USP Chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas
A proposal for USP chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas has been published for comments in the Pharmacopeial Forum, PF 48(5). It will apply to every link in the supply chain, such as manufacturers, wholesale distributors and third-party logistics providers. The new chapter should be viewed in the context of the United States Pharmacopeia's (USP) efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.
GDP Non-Compliance Report: No GDP conform Quality System
The competent authority of Germany (Thuringian State Authority for Consumer Protection) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database. The wholesale distribution authorisation (WDA) of the company concerned was suspended. Among other things, the authority criticized the lack of a GDP-compliant quality system.
GDP Non-Compliance Report: No WDA without Responsible Person
On 12 July 2022, the competent authority of Germany (Regierungspräsidium Karlsruhe) added a new GDP Non-Compliance Report to the EudraGMDP database. The reason given is the fact that there is no responsible person.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.
FDA issues revised draft Guidances for Track and Trace
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.
Alfred Hunt Appointed as New Chairman of the European GDP Association
Dr Afshin Hosseiny, who has been the European GDP Association's Advisory Board Chairman since its foundation, has decided to step down from this position. For this reason, Alfred Hunt joined as the Deputy Chair in 2021. After a year of the two working together, Alfred Hunt has now taken over the role as the Chairman.
GDP in the US: New USP Chapter <1079.3> on Devices for Temperature and Humidity Monitoring over Time
In the Pharmacopeial Forum, PF 48(4), a proposal for a new USP chapter <1079.3> Monitoring Devices—Time, Temperature, and Humidity, providing background information about the science and technology of temperature and humidity monitoring over time, has been published for comments.