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Subject:
From:
Bob Westney <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 6 Jul 2020 12:09:47 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (122 lines)
You'd certainly need to repeat method suitability testing if the
formulation changes.  Any process changes may need to have a risk
assessment, to determine if these changes impact the formulation of
stability characteristics (this would be performed as part of the process
re-validation approach).  Otherwise, there is no need to repeat method
suitability.

You didn't describe what "microbial testing" types you're referring to
(e.g., sterility, MLT, bioburden, etc.).  That being said, you may have to
perform partial method suitability testing for non-sterile products if you
find an objectionable organism in (e.g.) a raw material, using that
organism.  You may have to perform partial method suitability testing for
sterility if you have a sterility test or media fill failure, using that
organism.

Bob Westney
Director of Quality and Operations
Cryologics, Inc.
www.Cryologics.com

On Mon, Jul 6, 2020 at 10:56 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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> 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 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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