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

THE DRUG SPECIFICATION-SETTING PROCESS

This article was originally published in The Gold Sheet

Executive Summary

... is being reevaluated in the context of the new quality-by-design concepts and the more flexible regulatory paradigm they are targeting. At a recent FDA/PQRI workshop, regulators and industry focused on clinical relevancy, GMPs and the future of compendial standards in the search for how specifications can best assure that the product and process design is maintained without hindering manufacturing improvements. The advancing concepts of design space and process analytical technology are challenging FDA and USP to reassess the role that specifications play in their respective regulatory schemes. For USP, the issues raised about public standards and the way they are presented in the compendial monographs and general chapters are very much alive as the pharmacopeia enters its next quinquennial cycle.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS000073

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