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July 2020

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Subject:
From:
Dale Kelley <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 6 Jul 2020 15:31:14 +0000
Content-Type:
text/plain
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Kyriaki,
No, there is no periodic validation for test methods.
Additional validation is appropriate when you make changes to the test method or product.  Changes to testing conditions can also drive validation activities.

Hope this helps,

Dale Kelley
Director
Protocol Link, Inc.
175 E. Hawthorn Parkway, Suite 210
Vernon Hills, IL 60061 USA
cell +1-224-565-2790 || office +1-847-549-0390
www.protocollink.com





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Kyriaki Antoniou <[log in to unmask]>
Sent: Monday, July 6, 2020 2:59 AM
To: [log in to unmask]
Subject: [PMFLIST] Validation of microbial testing methods

Dear Forum,

Where microbial testing of a drug product is carried out, the method should be validated to confirm that the product does not influence the recovery of microorganisms. When the validation is completed, do we need to apply also periodic validation (e.g. once a year, every two years) to confirm that the method is still valid?




Best Regards

Kyriaki Antoniou

Microbiology Department Manager


Remedica Ltd

Tel.: +357 25-553000 | Direct Tel.: +357 25-553508 (Internal: 508) | Fax: +357 25-390192 Site address: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus-EU Mailing address:  Remedica Ltd, P.O. Box 51706, CY-3508, Limassol Cyprus-EU
Web: www.remedica.eu<http://www.remedica.eu/>

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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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