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Review ArticleReview

Cleaning Validation: Complete Guide for Health - Based Approach in Chemical Cross - Contamination Risk Assessment

Joseph N. Tanyous
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 204-210; DOI: https://doi.org/10.5731/pdajpst.2018.008946
Joseph N. Tanyous
HORUS for Pharmaceutical Industries, Giza, Egypt
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  • For correspondence: joseph.nashaat@evapharma.com
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References

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    European Medicines Agency. Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. EMA: (2014) https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf (accessed Feb 10, 2018).
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    Europe, the Middle East and Africa, (2003). ICH guideline Q3C (R6) on Impurities: Guideline for Residual Solvents. International Conference of Harmonisation, 68 (December 2016), 35. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/q3c-r6-impurities-guideline-residual-solvents-step-2b_en.pdf (Accessed February 10, 2018).
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    , Cleaning Validation: Defining Limits and Doing MACO Calculations. https://ispenordic.nemtilmeld.dk/images/descriptions/13540/20_april/02_Defining_Limits_and_Doing_MACO_Calculations__by_Pierre_Devaux.pdf (accessed February 10, 2018).
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    U.S. Food and Drug Administration, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry. 2016. https://www.fda.gov/downloads/Drugs/Guidances/ucm073497.pdf.
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PDA Journal of Pharmaceutical Science and Technology: 73 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
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Cleaning Validation: Complete Guide for Health - Based Approach in Chemical Cross - Contamination Risk Assessment
Joseph N. Tanyous
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 204-210; DOI: 10.5731/pdajpst.2018.008946

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Cleaning Validation: Complete Guide for Health - Based Approach in Chemical Cross - Contamination Risk Assessment
Joseph N. Tanyous
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 204-210; DOI: 10.5731/pdajpst.2018.008946
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    • Abstract
    • 1. Introduction
    • 2. Calculation Variables
    • 3. Risk Ranking (Bracketing Approach)
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Keywords

  • Cleaning validation
  • Cross - contamination risk assessment
  • Health - based exposure limits
  • Chemical swab limits
  • Chemical contamination

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