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October 2019


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Michael Barton <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 1 Oct 2019 19:45:40 +0000
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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?

perform suitability with media defined in chapter. perform suitability of alternative media. perform a comparison?
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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