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September 2019

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Subject:
From:
"Post, Scott" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 10 Sep 2019 12:50:35 +0000
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I'm interested in knowing what the industry interpretation of periodic health checks is as stated in the draft EU Annex 1 Section 4.7.

Section 4.7 High standards of personal hygiene and cleanliness are essential. Personnel involved in the manufacture of sterile preparations should be instructed to report any specific health conditions or ailments which may cause the shedding of abnormal numbers or types of contaminants and therefore preclude clean room access; periodic health checks for such conditions should be performed. Actions to be taken with regard to personnel who could be introducing an undue microbiological hazard should be described in procedures decided by a designated competent person.

Periodic health checks is a new requirement in the draft document.  Are periodic health checks the responsibility of the colleague for a specific medical condition or does this relate to a company medical surveillance program?

Thanks
Scott


Scott Post | Global Aseptic Support Leader
Zoetis | 10 Sylvan Way, Parsippany, NJ 07054
Office: +1-973-443-2957
Mobile : +1-862-777-3006
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Visit Us: zoetis.com<http://www.zoetis.com/>

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