News

GDP in the US: Drug Supply Chain Security Act (DSCSA) - Recent Updates

In the US, there is currently a lot going on in the area of GDP. In recent weeks and months, the FDA has published several new documents related to the Drug Supply Chain Security Act (DSCSA).

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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.

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Two new GDP Non-Compliance Reports Published in June 2022

In June 2022, two new GPD Non-Compliance Reports were entered into the EudraGMPD Database.

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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.

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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?

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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.

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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.

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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.

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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".

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GDP-relevant Documents from FDA and USP Currently in Commenting Process

Currently, several GDP-relevant documents from the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) are in the commenting process. We have prepared an overview.

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