Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Pharma Raises Concerns About Draft EU GDP Guideline

This article was originally published in The Gold Sheet

Executive Summary

The European Commission needs to fine tune its good distribution practices (GDP) guideline, the pharmaceutical industry said in comments on a proposed draft revision. Key issues include segregating EU and non-EU product, transportation vs. storage conditions, applicability to investigational products and time limits for transportation hubs.

You may also be interested in...



Regulatory Authorities Worldwide are Scrutinizing GDPs During Inspections

Regulators worldwide are increasingly scrutinizing pharmaceutical manufacturers’ good distribution practices during GMP inspections as GDP regulations continue to proliferate, says an industry representative who discusses how to comply with different regulations.

Regulatory Authorities Worldwide are Scrutinizing GDPs During Inspections

Regulators worldwide are increasingly scrutinizing pharmaceutical manufacturers’ good distribution practices (GDPs) during GMP inspections as GDP regulations continue to proliferate, says an industry representative who discusses how to comply with different regulations and notes some of the challenges in instituting robust GDPs. USP is the latest player in the increasingly crowded GDP arena.

The Anti-Falsification Directive: Europe’s Answer to Global Supply Chain Threats

The European Union July 1 published its directive on falsified medicines, setting into motion a tightening of Europe’s pharmaceutical supply chain that will for the most part take place over the next 18 months – and that could cost pharmaceutical companies billions of Euros.

Topics

UsernamePublicRestriction

Register

OM008605

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel