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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 6 Jul 2020 17:47:35 -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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Yepwi,

No you are not required to repeat the method suitability testing with each
staff change.

The expectation is that the analyst will have the education, skills and
experience to follow the method as written in the SOP and
successfully conduct the test.

Tony

On Mon, Jul 6, 2020 at 4:13 PM Henry Yepwi <
[log in to unmask]> wrote:

> Good evening, Sir/Ma
> To answer the question, once the validation is complete, a periodic review
> isn't necessary unless there is a modification in the product or method of
> analysis, then a validation needs to be carried out. To also add, if a new
> staff is also employed to the office or for the case of competency
> assessment, that can be carried out.
> Hope this is helpful.
> Thank you
> Yepwi Henry.
> Microbiology Sent from Yahoo Mail on Android
>
>   On Mon, Jul 6, 2020 at 3:55 PM, Kyriaki Antoniou<
> [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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> =================================
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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
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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
>
> 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
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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.
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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

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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