Good Distribution Practices News

16.08.22

Amazon Receives Warning Letter from FDA

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.

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27.07.22

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.

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26.07.22

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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26.07.22

Two new GPD 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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26.07.22

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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26.07.22

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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13.07.22

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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22.06.22

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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14.06.22

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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14.06.22

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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14.06.22

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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12.05.22

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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12.05.22

RP for GDP: Which Duties can be Delegated?

The area of responsibility of the Responsible Person for Good Distribution Practice is quite extensive. Therefore, the question arises which tasks actually have to be performed personally and which duties can be delegated.

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12.05.22

FDA posts Webinar on Proposed Rule for the Licensure of WDDs and 3PLs

The U.S. Food and Drug Administration (FDA) has posted a webinar on the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The webinar aims to help stakeholders submit comments and understand the proposed changes.

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10.05.22

Are You Recall Ready?

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

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