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 

Intelligence Services
21 CFR Part 11
Competency Training
Blend Uniformity
Patent databases

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


Reliable test results provide necessary proof of quality of products. Reliable test results can be achieved if and only if,

  • The method used has been scientifically validated and in compliance of GMP regulations & method validation guidelines of the ICH & the FDA,
  • SOPs, which cover all aspects of sampling and determination, are well written, accurate, consistent, executable, and in compliance of GMP regulations,
  • Employees are trained and their competencies are documented,
  • SOPs have been followed accurately for sampling and determinations as required,
  • The measurement system is in state of statistical control,
  • Electronic records & electronic signatures comply to 21 CFR Part 11,
  • Non-electronic records and handwritten signatures comply with GMP.


Out of specification (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.

Out of trend (OOT) results includes all suspect results that fall outside the trend specifications or acceptance criteria for the trends established in new drug applications, official compendia, or by the manufacturer.

OOS results can be classified into one (1) of three (3) categories:

  • laboratory error,
  • non-process related (e.g., manufacturing equipment) or operator error,
  • process related or manufacturing process error.

  • Each technique must be considered specifically relative to OOS & OOT investigations.

    Laboratory errors occur when analysts

  • make mistakes in following the SOPs,
  • uses incorrect standards, and/or
  • uses incorrect materials, and/or
  • uses incorrect supplies, and/or
  • simply records the results erroneously, and/or
  • miscalculates the data, and/or
  • simply does not have sufficient level of competency in carrying out the analysis.
  • We shall be concerned with recognizing laboratory errors in QC testing, the relevant competency requirement of the analysts and supervisors, preventative strategies to minimize OOS & OOT, and the process of effective investigations to resolve OOS & OOT.

    OOS (Out-of-Specification) - FAQ

    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.