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June 2020

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Subject:
From:
"Shah, Samir" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 12 Jun 2020 14:04:38 +0000
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text/plain
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Hello Mike,

My personal recommendation is that you create an SOP or protocol detailing phase specific method validation/suitability plan. You start with one iteration of method suitability to ensure the product can be adequately dispersed and you have adequate neutralization/recovery. Continue to build as the formulation gets finalized in advance stages of development.

The expectation would be that you have three iterations of method suitability on preferably three batches by pivotal trial or validation batch including the method suitability/transfer at the commercial release site lab. The method validation plan/protocol/SOP must be approved by your QA as well as regulatory affairs. Any changes in the proposal must be amended and included in CMC section to ensure traceability.

Disclaimer: The scientific opinion presented above is based on my own education and experience.

Samir Shah,Ph.D.
Mobile +1 732-221-9001



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Michael Barton
Sent: Friday, June 12, 2020 4:09 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Method suitability for phase 1 - non-sterile product

[Use CAUTION when opening links/attachments]

Hi,
does anyone have any information to support this. Im really struggling to find information during these earlier phases.

Aanyone who works in these earlier phases or consultants and have any detail they can share would be really appreciated.

Thanks Mike
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Michael Barton <[log in to unmask]>
Sent: 02 June 2020 15:37
To: [log in to unmask] <[log in to unmask]>
Subject: [PMFLIST] Method suitability for phase 1 - non-sterile product

Hi All,
during the early phases of product development and up to clinical trials where it is intended to test a product to <61> & <62> to what extent does the method need to be assessed/validated and  suitability performed?

Thanks
Mike.

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Steris - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterislifesciences.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7Cc5effbbdf15146e6f3c508d80ed7480f%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637275665086648073&amp;sdata=WT2VpwfsvhSJIH2FlAZbQFqpzVMOI844G01v%2FPm6L3g%3D&amp;reserved=0

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Associates of Cape Cod, Inc. - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.acciusa.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7Cc5effbbdf15146e6f3c508d80ed7480f%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637275665086658068&amp;sdata=DC1wTnyuyU8h2SS%2FFcbXlr5g242PYG%2B%2FO8zGCtToVGQ%3D&amp;reserved=0


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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 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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