Good Distribution Practices News

19.08.19

FDA Blockchain Pilot

The US FDA has selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security.

19.08.19

Hard Brexit: MHRA Preparations

The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario.

07.08.19

Version 15 of the Q&As on Safety Features

The European Commission published version 15 of the Q&A´s on Safety features for medicinal products for human use. The new version includes a revision of the Q&A on safety features relating to IMPs.

24.07.19

Safety Features - how is it progressing?

The MHRA will be issuing a series of blog posts regarding the implementation of the FMD over the next few months. The first post looks at the robustness of incoming checks.

24.07.19

Defect Catalog for Films and Foils

A technical guide on commonly used insulation materials has recently been provided in form of a stimuli article in Pharmacopeial Forum. In particular, a defect catalog for common thermal system components with detailed examples of potential failures is provided.

17.07.19

New Zealand proposes new legislation for medical cannabis

New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.

23.05.19

GDP-Inspector: Why Supplier Qualification is important

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.

23.05.19

New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site.

23.05.19

New WHO Draft for GDP Guidance

The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.

08.05.19

Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

03.04.19

Drug Shortages due to Brexit: EU gives Answers

The EMA has published a question-and-answer document on possible supply bottlenecks after Brexit.

21.03.19

Brexit: GDP Updates for Import Activities and Air Freight

MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.

21.03.19

Hard Brexit: Liability Risk for Carriers

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

21.03.19

Delivery of not ordered goods - what to do?

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

14.02.19

FDA: New Steps to improve Supply Chain Security

The US Food and Drug Administration (FDA) is launching a new pilot project for enhanced tracing and verification approaches in the pharmaceutical distribution supply chain.

Page 15 of 24

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Good Distribution Practices News

FDA Blockchain Pilot

Hard Brexit: MHRA Preparations

Version 15 of the Q&As on Safety Features

Safety Features - how is it progressing?

Defect Catalog for Films and Foils

New Zealand proposes new legislation for medical cannabis

GDP-Inspector: Why Supplier Qualification is important

New office-based GDP-Inspection Process in UK

New WHO Draft for GDP Guidance

Q&As on Safety Features - Version 14

Drug Shortages due to Brexit: EU gives Answers

Brexit: GDP Updates for Import Activities and Air Freight

Hard Brexit: Liability Risk for Carriers

Delivery of not ordered goods - what to do?

FDA: New Steps to improve Supply Chain Security

Recommended Event

Qualified Person Education Course Module B PLUS pre-course Session: “Interpersonal and Soft Skills for the QP”

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