OPULUS
Welcome Guest (Log in, Subscribe
 What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription 


Last update:2012.04.04.
 Regulatory Basis  Forum Issues  Intelligence Services  Web Applications  21 CFR Part 11 Compliant Products 

Search: 
Intelligence Services
Endotoxin
OOS
21 CFR Part 11
Dissolution
Competency Training
Blend Uniformity
Validation
Patent databases


Adobe Acrobat Reader
Where are you now? Intelligence Services > OOS > Related Regulations

OOS (Out-of-Specification) Regulations

These files are in Adobe PDF format.
Click on the "Get Acrobat Reader" icon on the left of the page to
download a free copy of the Acrobat Reader.

sort by
Title
sort by
  Date  
 Download 

Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
This guidance for industry provides the Agency's current thinking on how to evaluate suspect, or out of specification (OOS), test results. For purposes of this document, the term OOS results includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications, official compendia, or by the manufacturer, FDA

 1998-01-01   PDF PDF file (37 KB) 

Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
PDA comments on the draft guidance for industry, Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production, September 30, 1998.

 1998-01-01   PDF PDF file (56 KB) 

U.S. vs. Barr Laboratories: A Technical Perspective
A ruling dated February 4, 1993, Judge Alfred Wolin of the U.S. District Court for the District of New Jersey handed down a ruling that has already shaped interpretation of the pharmaceutical CGMP regulations by industry and the FDA. This case resulted from numerous FDA inspections of Barr's plants in Northvale, New Jersey and Pomona, New York in mid-1991 and 1992.

 1993-09-13   PDF PDF file (40 KB) 

Click here if you have not found what you were searching for.

21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
Warning Letters Knowledge Base
An extremely versatile database that will assist familiarization with the regulatory requirements
Competency Trainings & Exams
Multimedia enriched learning materials, exercises and exams.
On-line Trainings & Exams
Web-based learning materials, exercises and exams

back Back
----------------------------------
--| What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription |--
© 2001-2003 OPULUS® is licensed to BioMondex Ltd. All rights reserved. Please read the disclaimer.