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Sources
  1. Kim A., Gehrmann M.R., McCaw, J., McAndrew T.P. How to Qualify Container Closure Systems for Intended Use, Part 1. International Journal of Pharmaceutical Compounding. 2019; 23(6): 454-461.
  2. Food and Drug Administration. Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry), December 2018; Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM403496.pdf. Accessed 22 November 2019.
  3. United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products (2016).
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Amy Kim

Amy Kim

Sr. Specialist, Scientific Communications

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