Good Distribution Practices News

06.02.18

GDP Deficiency Data available

The British Medicines and Healthcare Products Regulatory Agency (MHRA) has published a report summarising GDP inspection deficiency data from its 2016 inspections.

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06.02.18

Company cited by FDA for poor Transportation Practice

The US FDA published a form 483 criticising the shipping practice of a pharmaceutical company. They simply ignored temperature excursions and respective complaints.

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06.02.18

Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline

The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs). Please read more about the new Questions and Answers on GDP

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10.01.18

Switzerland: important Amendments to the MRA

Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.

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12.12.17

GDP Issues cited in Non-Compliance Report

A new Non-Compliance Report for parallel import, repacking and distribution of pharmaceutical products was published on the EudraGMDP site.

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12.12.17

Will there be an ISO Standard for Refrigerated Parcel Deliveries?

The British Standards Institution (bsi), Group Japan, has developed a so called PAS (Publicly Available Specification) to specify requirements for temperature-controlled delivery services for chilled and frozen goods.

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12.12.17

Does FDA enforce GDP?

GDP Guidelines are certainly a hot topic in the EU and in WHO states. In the US, things are still developing but are getting more and more important, as the excerpts from recent Warning Letters addressing GDP isssues show.

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02.11.17

Violation of GDP Guidelines and Counterfeiting of Medicines - a Current Case Demonstrates the Dangers

The trade press has extensively covered the counterfeit of Harvoni, a pharmaceutical produced by Gilead. The background circumstances as well as the consequences to be drawn from this incident are of interest here. Read more about the counterfeit case and the GDP consequences.

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02.11.17

European GDP Association nominates two new Advisory Board Members

The European GDP Association has been growing steadily since its foundation as Good Distribution Practice Interest Group in 2013. Now it represents close to 1.900 professionals from all over the world. Recently the Association announced that two new members joined the Advisory Board.

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30.08.17

Brexit: the British comment

After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future.

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17.08.17

Loophole in GDP Legislation puts Medicinal Products at Risk

The European Institute for Pharma Logistics (EIPL) conducted a field study on drug deliveries by online pharmacies - with some alarmingly results. Find out more about the EIPL field study.

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17.08.17

Distribution to the US: quicker Import Decisions

FDA's new automated system to assist in making import decisions for FDA-regulated products seems to shorten up processing time, according the agency. Learn more about the FDA Automated Commercial Environment/International Trade Data System.

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17.08.17

Do Manufacturers need Pharmacovigilance (PV) Agreements with Wholesalers?

Marketing Authorisation Holder (MAH) might require Pharmacovigilance Agreements with Wholesale Distributors according to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

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06.07.17

How to use Freezers and Refrigerators

In a recent post MHRA describes some of the main issues with freezers used by pharmaceutical wholesalers.

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06.07.17

GDP: Questions & Answers about the Scope of the EU-GDP Guidelines

Do the EU-GDP Guidelines apply for Veterinary products and IMPs? These questions are answered in a new set of Q&As of the European GDP Association.

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