Evaluation of Stability Data


This chapter discusses the evaluation of stability data. It follows the \hbox{stability} study information from the point that raw data is generated in the lab, calculations are performed to give test results, and test results are entered in the stability summary sheets, until data is finally entered into a stability report for submission purposes. This chapter also includes a summary of data evaluation addressed in ICH Q1E and a discussion of Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations. Specification setting and shelf-life extrapolation, which are performed after evaluating stability data, are also described in this chapter.


Control Chart Drug Product Drug Substance Acceptance Criterion Stability Data 
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  1. 1.
    International Conference on Harmonization (2003) Q1A(R2): Stability testing of new drug substances and products (second revision).Google Scholar
  2. 2.
    International Conference on Harmonization (2003) Q1E: Evaluation of stability data.Google Scholar
  3. 3.
    PhRMA CMC Statistics and Stability Expert Teams (April 2003) Identification of out-of-trend stability results. Pharm Technol pp 38–52.Google Scholar
  4. 4.
    FDA (1998) Guide to inspection of quality control laboratories.Google Scholar
  5. 5.
    FDA/CDER (October 2006) Guidance for industry: Investigating out-of-specification (OOS) test results for pharmaceutical production.Google Scholar
  6. 6.
    International Conference on Harmonization (1999) Q6A: Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances.Google Scholar
  7. 7.
    International Conference on Harmonization (1999) Q6B: Specifications: test procedures and acceptance criteria for biotechnological/biological products.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Biologics Consulting Group, Inc.PlainsboroUSA
  2. 2.Pharmalytik ConsultingNewarkUSA

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