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October 2019

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Subject:
From:
"Rabia Begum (Manager Microbiology)" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 2 Oct 2019 04:49:15 +0000
Content-Type:
text/plain
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text/plain (224 lines)
Thanks for your valuable input regarding Microbial examination test. We do consider following three as Pharmacopeial and perform suitability test in the presence of products to demonstrate adequate neutralizer toxicity and efficacy.

1. Buffered Sodium Chloride-Peptone Solution pH 7.0
2. Phosphate Buffer Solution pH 7.2
3. Soybean–Casein Digest Broth

With regards,
Rabia Begum
Quality Control Department
Ext. 2371


“Please consider your environmental responsibility before printing this e-mail or its attachments”


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Robert Pritchett
Sent: Wednesday, October 02, 2019 12:09 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Modification in Microbial examination test for Non-sterile products

I respectfully disagree the use of TSB (Soybean-Casein Digest Broth in USP lingo) would be considered an alternative method to the compendial assay. It's one of three options listed in <61> as a starting diluent in the text:

1. Buffered Sodium Chloride-Peptone Solution pH 7.0 2. Phosphate Buffer Solution pH 7.2 3. Soybean–Casein Digest Broth

However, if one wishes to change from an established suitable method that uses option 1 to a different suitable method using option 3, I'm interested in opinions on whether it requires a comparison study or just a simple standalone method suitability verification.

-RP


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Dr. Michael J. Miller (External)
Sent: Tuesday, October 01, 2019 9:10 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Modification in Microbial examination test for Non-sterile products

Any deviation from the compendial assay requires validation to show the alternative method is equivalent to the existing method. Regards, Michael



From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of "Rabia Begum (Manager Microbiology)" <[log in to unmask]>
Reply-To: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date: Tuesday, October 1, 2019 at 10:34 AM
To: <[log in to unmask]>
Subject: Re: [PMFLIST] Modification in Microbial examination test for Non-sterile products



Dear Members,

I have a query regarding alternate microbiological methods. For non-sterile product testing if we use TSB in place of Buffered peptone for preparation of 1:10 dilution. Does this modification classify in alternate method or it can be still consider as Pharmacopeial method?



Your expert opinion is required for the compliance of Pharmacopeial requirement.



With regards,

Rabia Begum

Quality Control Department





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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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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.
Disclaimer: “This message (including attachment) is intended solely for the use of the individual or entity whom it is addressed and may contain information that is confidential or privileged. If you are not the intended recipient of this message, you are hereby notified that any use, dissemination, distribution or reproduction of this message is prohibited and that, you must not take any action in reliance on it. E-mail transmission cannot be guaranteed to be secure or error-free as information could be intercepted, corrupted, lost, destroyed, arrived incomplete or contain viruses; therefore Getz Pharma (Private) Limited cannot accept legal responsibility for the contents of this message. If you have received this communication in error, please notify the sender or Getz Pharma (Private) Limited at [log in to unmask] immediately and destroy the original message.”

------------------
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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