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July 2020

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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 6 Jul 2020 11:18:51 -0400
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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From:
Tony Cundell <[log in to unmask]>
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Kyriaki,

I recommend that you view method suitability testing as a qualification not
a validation as compendial methods being official are considered validated.

Method suitability testing would only be repeated if there was a
significant change, e.g., change in formulation, manufacturing process or
test method.

Tony

On Mon, Jul 6, 2020 at 10:52 AM Kyriaki Antoniou <[log in to unmask]>
<[log in to unmask]> wrote:

> 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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> [cid:image011.png@01D4FB72.4AE7DD60]
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> 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
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> Microbiologics, Inc. - http://www.microbiologics.com
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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The PMFList is supported by our sponsors as a service to the scientific community.

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/


=================================
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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