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Sources

1. Vaughan S.R. and Radwick A. How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems. International Journal of Pharmaceutical Compounding. Jan/Feb 2020; 24(1): 14-19.

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) January 2020. Available at: https://www.fda.gov/media/88905/download. Accessed 20 February 2020.

3. United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products (2016).

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West Pharma

Melanie Prudom

Director, Market Insights

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