HBW Insight is part of the Business Intelligence Division 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

FDA's RISK-BASED QUALITY INTIATIVE

This article was originally published in The Gold Sheet

Executive Summary

...is designed to ensure that the various GMP and CMC programs the agency has launched for improving the regulatory framework are integrated, systematized and strengthened. The new initiative is based on the principle that unleashing analytical technology is the most effective way to manage risk and streamline the quality regulatory process. With FDA and industry management backing, the vision of a new manufacturing and control paradigm is becoming a reality. [FDA policy developments since 1995 leading to the risk-based initiative are outlined.]
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS000044

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