Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Outsourcing Production Is First Step In Staving Off GMP Consent Decrees

This article was originally published in The Tan Sheet

Executive Summary

Outsourcing manufacturing as soon as GMP violations are identified can help firms avoid FDA enforcement, making available extra resources to assess and enact remediation, experts advise. Open, company-wide communication and celebrating successes while remediating under a consent decree also are key, too.

You may also be interested in...



J&J Prioritizes OTC Return With McNeil Remediation End In Sight

Johnson & Johnson CEO Alex Gorsky says bringing recalled OTCs such as Tylenol and Motrin products back to market is the firm’s “clear number one priority” in the near term. J&J also has a timetable for completing its responsibilities under a consent decree with FDA in place since 2011.

J&J Consumer Sales Slip Even As Recalled Brands, Seasonal Items Reach Stores

J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.

Ensuring Leading Position For GSK Consumer Products Touted In Management Shift

GlaxoSmithKline restructures its management to ensure adequate focus on its three core areas, pharmaceutical, vaccine and consumer. Consumer product sales fell 3% to $1.72 billion in the third quarter due to continuing supply interruptions and generally weaker markets.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS107398

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