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

GMP CONSENT DECREES

This article was originally published in The Gold Sheet

Executive Summary

...are prompting pharmaceutical executives industry-wide to reevaluate their commitment to quality control as financial costs associated with the agreements escalate. Schering-Plough's $500 mil. "disgorgement of profit" is the largest such penalty levied in FDA's effort to magnify the deterrent power of the decrees. The agreements stipulate remedies, such as the use of outside consultants, meant to address the deficiencies in corporate culture that allow recidivism to become a problem. Industry experts advise firms with recurrent compliance problems to proactively implement consent decree-like corrective actions to forestall injunctions. Companies like Abbott already operating under a decree are finding that costs are mounting as they struggle to meet the tough strictures involved. FDA and industry agree that better clarification of GMP expectations and the implementation of advanced control technologies could help reduce the cost of enforcement and improve quality.

You may also be interested in...



McKinsey Survey Highlights Progress, Challenges in Adoption of QbD

Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.

Manufacturers Encouraged to Enhance Clinical Relevance of Quality With QbD

Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.

Biotech QbD Encounters Uncertainties Over Definitions and Regulatory Relief

As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.
UsernamePublicRestriction

Register

PS000041

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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