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June 2020

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Subject:
From:
Rick Jakober <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 12 Jun 2020 14:27:49 +0000
Content-Type:
text/plain
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Hi Mike,

As a contract lab I have seen a few different approaches:
1. The developer tests only the raw materials for <61> and <62> to ensure that the materials being used are "clean" microbiologically. This is because the early formulation process is often on a lab scale or small pilot scale process (so there may only be limited materials available or it is being formulated in a "non-GMP" environment). 
2. When I have tested early development products (lab scale), I have found the occasional product contamination especially in aqueous formulations. These were almost always traced back to a screw-up on the lab scale formulation. 
3. All of the early development stages have suitability performed and the <61> and <62> run. This seems to be limited to larger pharma groups.
Or
4. No testing until a "GMP" batch is manufactured.

A lot depends on doing a risk assessment on the material. Aqueous and high water activity materials (like chewable gummy products) are much more likely to have microbial issues than say solid compressed tablets so some companies will do micro depending on the risk. 

My personal opinion is that at minimum, the raw materials used for the product development (regardless of how early a stage) should be tested for micro. Aqueous or at microbial risk products should also be tested. Any other product that regulatory agencies might even have the slightest interest in should be tested as well.

Rick Jakober
Perritt Laboratories, Inc.

-----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

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 - 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

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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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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 contact [log in to unmask]



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.

------------------
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 contact [log in to unmask]



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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