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October 2019

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Subject:
From:
Dale Kelley <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 11 Oct 2019 16:51:47 +0000
Content-Type:
text/plain
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text/plain (133 lines)
Michael,
USP <61> does have provisions for using a quantity of less than 10g under "Amount Used for the Test".
If your product does not fit into one of the exceptions, then you would need to justify a different sampling plan, and have it authorized.

Regards,

Dale Kelley
Director
Protocol Link, Inc.
175 E. Hawthorn Parkway, Suite 210
Vernon Hills, IL 60061 USA
office +1-847-549-0390
www.protocollink.com





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Michael Barton
Sent: Friday, October 11, 2019 6:12 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] <61> defining amount to be tested.

Hi All,
is anyone able to help me with this query. thanks

If a single use product (non-sterile powder) is 50mg with active part 2mg and the product was extremely expensive and only manufactured in 1000units per batch (50g) are you expected to pool together 200units in order to obtain 10g to be tested.

This seems impractical taking a lot of the batch and potentially at a very high cost.

________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Michael Barton <[log in to unmask]>
Sent: 27 September 2019 07:27
To: [log in to unmask] <[log in to unmask]>
Subject: [PMFLIST] <61> defining amount to be tested.

Hello all,

If a single use product (non-sterile powder) is 50mg with active part 2mg and the product was extremely expensive and only manufactured in 1000units per batch (50g) are you expected to pool together 200units in order to obtain 10g to be tested.

This seems impractical taking a lot of the batch and potentially at a very high cost.

Thanks Mike


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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/


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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.
This message and any attachments may contain PRIVILEGED AND CONFIDENTIAL INFORMATION of Protocol Link, Inc. If you are not the intended recipient(s), you are hereby notified that any distribution, copying, or disclosure of the contents of this message or any attachment containing privileged and confidential information is STRICTLY PROHIBITED. Please notify the sender immediately by e-mail and then delete this message.

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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/


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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.

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