GMP Compliance During Development
- PDF / 681,982 Bytes
- 9 Pages / 504 x 720 pts Page_size
- 2 Downloads / 236 Views
GMP Compliance during Development David J. DeTora Drug Information Journal 1999 33: 769 DOI: 10.1177/009286159903300316 The online version of this article can be found at: http://dij.sagepub.com/content/33/3/769
Published by: http://www.sagepublications.com
On behalf of:
Drug Information Association
Additional services and information for Drug Information Journal can be found at: Email Alerts: http://dij.sagepub.com/cgi/alerts Subscriptions: http://dij.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav Citations: http://dij.sagepub.com/content/33/3/769.refs.html
>> Version of Record - Jul 1, 1999 What is This?
Downloaded from dij.sagepub.com at COLUMBIA UNIV on November 12, 2014
Drug I n f o m r i o n Journal, Vol. 33. pp. 169-176, 1999 Printed in the USA. All rights reserved.
0092-8615199 Copyright 8 1999 Drug Information Association Inc.
GMP COMPLIANCE DURING DEVELOPMENT DAVIDJ. DETORA Senior GMP Compliance Associate, Merck Research Laboratories, Rahway, New Jersey
Requirements for assuring Good Manufacturing Practices (GMP) compliance during the development of active pharmaceutical ingredient (API)processes and the preparation of APIs for clinical use present a significant challenge to development scientists. Development environments are characterized by frequent changes during optimization activities; specifications, process conditions, and scale continue to be modified as any product approaches approval. Until recently, available guidance was silent on GMP considerations for APIs used during clinicul studies. Just as the spectrum of GMP considerations for API processing imposes increusing scrutiny from initial intermediates through the final active ingredient, esculating requirements exist for API process development from the first lot to the biobatch or pivotal trial material. Industry perspectives on appropriate controls for these interdependent GMP considerations will be discussed. Key Words: Active Pharmaceutical Ingredients (API); Compliance; Development; Good Manufacturing Practices (GMP)
INTRODUCTION COMPLIANCE WITH GOOD manufacturing practices is required for the preparation of active pharmaceutical ingredients used in the development of new drug products. Previous guidance from regulatory agencies (1,2) has been silent on the application of GMP to the API development area. Recent efforts toward producing guidance for API development has only progressed to a draft document (3). Consequently, interpretation of guidances developed for drug product development (2) or API commercial manufacture (1) and industry publications (4,5,6)
Presented at the DIA Fourth Symposium on Active Pharmaceutical Ingredients, “Issues at the Development, Production, Regulatory Interface,” November 811. 1998, Baltimore, Maryland. Reprint address: David J . DeTord, Sr. GMP Compliance Associate, Merck Research Laboratories. PO Box 2000, RY80Y-220, Rahway, NJ 07065.
have been used as the basis of GMP programs during development.
Data Loading...
