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

ACTIVE PHARMACEUTICAL INGREDIENT QUALITY ASSESSMENT 

This article was originally published in The Gold Sheet

Executive Summary

...will be supported by a more unified guidance effort as FDA strives to ensure that the benefits of its quality initiative reach into the API world. The agency and industry are debating what quality by design means in the API context and whether an ICH effort is needed to better define drug substance development expectations and to leverage QbD knowledge internationally. Critical quality attributes are emerging as a potential focal point for API submissions in pursuit of a more flexible and improvement-friendly regulatory approach. Tightening the linkage between API and dosage form manufacturers is a challenge in reaching the desired state. FDA is bringing its foreign inspection program under the quality initiative umbrella and using Q7A as a GMP roadmap.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS000078

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