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June 2020


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"Voigt, Thomas" <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 23 Jun 2020 19:40:57 +0000
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Hello Forum,

For ready to use materials (vials, syringes, stoppers, seals) for sterile products, is there any guidance on only performing CofA testing on some receipts vs. every received receipt?  I am looking more to not perform sterility/endo/dimensional testing on every single lot.  Is it just a risk assessment that needs to be performed or certain amount of receipts tested per year?


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