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October 2019

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Subject:
From:
Michael Barton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 11 Oct 2019 11:10:03 +0000
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Hi All,
is anyone able to help me with this query. thanks

if you want to make some changes to a compendial method do you need to have performed suitability fully in line with the compendial method first or can you make the changes and prove that they are equivalent during suitability testing?

e.g if you change a media type what do you need to do?

  1.
perform suitability with media defined in chapter. perform suitability of alternative media. perform a comparison?
  2.
use the alternative media in your suitability and use if it meets criteria it is a validated modification

How do you do the comparison?
Does it have to be done at the same time with current results obtained or can you compare your modified method results to the compendial method if it was validated several years earlier?
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Michael Barton <[log in to unmask]>
Sent: 01 October 2019 19:45
To: [log in to unmask] <[log in to unmask]>
Subject: [PMFLIST] Modification to compendial methods

Hi All,
if you want to make some changes to a compendial method do you need to have performed suitability fully in line with the compendial method first or can you make the changes and prove that they are equivalent during suitability testing?

e.g if you change a media type what do you need to do?

  1.
perform suitability with media defined in chapter. perform suitability of alternative media. perform a comparison?
  2.
use the alternative media in your suitability and use if it meets criteria it is a validated modification

How do you do the comparison?
Does it have to be done at the same time with current results obtained or can you compare your modified method results to the compendial method if it was validated several years earlier?

Thanks Mike

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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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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]



Science Advisory Board https://www.scienceboard.net/

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

Charles River Laboratories - http://www.criver.com/

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

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

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

Boston Analytical http://www.bostonanalytical.com/

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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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