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.
Serialization - Version 20 of the Q&As on Safety Features
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?
EMA: Another Update of the Q&As on Parallel Distribution
Already in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website - as already reported recently. Now, the Q&As have been updated again and supplemented.
Comment Period Extended for the Proposed Rule for the Licensure of WDDs and 3PLs
The U.S. Food and Drug Administration (FDA) has extended the comment period for the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)" to September 6, 2022. The FDA believes that this extension allows adequate time for interested stakeholders to submit comments.
GDP Non-Compliance Report: Failure to Meet the GDP Principles of Cold Chain Products
The competent authority of Portugal (National Authority of Medicines and Health Products, I.P.) has entered a new GPD Non-Compliance Report into the EudraGMDP database. According to the authority, the wholesaler concerned does not comply wth the GDP principles of cold chain products.
Acting as a MHRA Approved Compliance Monitor for GDP
The Medicines and Healthcare products Regulatory Agency (MHRA) began a pilot programme for monitoring GMP and GDP activities, whereby approved consultants, so-called Compliance Monitors (CM), will supervise the completion of an agreed Compliance Protocol (CP). Consultants interested in being named as eligible to act as a CM for GDP (or GMP), have to fill out the MHRA "Compliance Monitor (CM) Application Form".