News

Poor GMP/GDP Practice found in US Warehouse

In a warehouse in Arkansas, USA, the US Food and Drug Administration (FDA) found "alarming" insanitary conditions.

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GDP Association updates Code of Practice for the Responsible Person for GDP

The Code of Practice "The Responsible Person for GDP" has been revised. The new Version 2 has just beed issued for members of the European GDP Association.

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Supply Chain and Drug Shortages Problems

What are the supply chain and drug shortage problems often caused by GMP and quality related problems? To find out more about this issue and about the consequences of drug shortages on the key stakeholders - i.e. the patients, companies and the governments -  the ECA conducted a survey. It also addressed potential strategies industry and authorities can employ to minimise the risk of drug shortage or its impact. Find out what the ECA survey on drug shortage problems brought to light.

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Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. The specific question of bundle packaging has also been addressed. Get more information about bundle packaging in EU's Q&A document on the safety features.

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"Ambient", "Room Temperature", "Cold " - what is what?

What are the regulatory requirements behind "ambient", "room temperature" and "cold chain"? The answer to the meaning of different storage conditions is not that easy.

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New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment)

The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).

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Regulatory Expectations for Contract RPs

For some wholesalers, the concept of using an external Responsible Person might be useful. But there a few things which need to be considered.

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CMDh Clarifications on the Implementation of the Falsified Medicines Directive

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

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EMA: More GMP/GDP Inspections performed

Almost 2.500 GMP inspections were performed last year by EU/EEA inspectors. And still many of them in the US.

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What makes a good RP?

In its blog the Medicines and Healthcare products Regulatory Agency (MHRA) explains what the UK authority expects from a Responsible Person: knowledge, experience, training.

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