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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:
Mon, 20 Jul 2020 17:38:47 +0000
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With so many industry experts being part of the USP committee, how come USP keeps issuing chapters with such confusing terms? Why no one holds them accountable for providing clarity? This always happens in microbiology sections and not in analytical.

-Samir




-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Donald English
Sent: Monday, July 20, 2020 11:47 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Chapter <60>

[Use CAUTION when opening links/attachments]

Dear Tony,

I do agree that WFI is not used in the manufacturing of non-sterile products.  However, it is stated in the chapter that it is recommended pharmaceutical waters should be tested for Burkholderia cepacia complex.

Some people may think that they have to test WFI because it is a pharmaceutical water.  The presence of the term “pharmaceutical water” is misleading in the chapter and people may think otherwise.  It would have been better if the chapter had stated that water that is used in the manufacturing of non—sterile should be tested for the presence of Burkholderia cepacia complex to prevent people in applying this chapter to WFI.

Don

Donald J. English Microbiological Quality Consulting LLC Florham Park, New Jersey 07932 Sent from my iPhone

> On Jul 20, 2020, at 10:13 AM, Tony Cundell <[log in to unmask]> wrote:
>
> Don as WFI is not used for the manufacturing of non-sterile products
> there would be no reason to test it for Bcc.
>
>> On Sun, Jul 19, 2020, 10:16 PM Donald English
>> <[log in to unmask]>
>> wrote:
>>
>> Hi Allison,
>>
>> I see that no one had responded back to your posting about using USP
>> Chapter 60 in a sterile manufacturing facility.
>>
>> In the introduction of USP Chapter 60, it is stated as follows:
>>
>> The tests are designed to determine whether a substance or
>> preparation complies with an established specification for
>> microbiological quality and/or to evaluate whether
>> products—especially those for inhalation use or aqueous preparations
>> for oral, oromucosal, cutaneous, or nasal use—contain members of the Bcc.
>>
>> In reality, there is no reason for using USP Chapter 60 because the
>> chapter is for non-sterile aqueous and inhalation products based upon
>> the introduction of the chapter.  However, it is stated in the
>> testing product section that it may be used for the testing of
>> pharmaceutical waters.  It would be interesting to see if regulatory
>> authorities would require Water-for-Injection that is used for making
>> sterile product formulations be tested for the presence of
>> Burkholderia cepacia complex by using the methodology of this chapter
>> by having this particular sentence in the chapter.
>>
>> By having this sentence present in the chapter, I would suspect that
>> you would be required to conduct Burkholderia cepacia complex of
>> collected Water-for-Injection samples because it is kind of vague of
>> what is meant as pharmaceutical water in the chapter.  From my
>> perspective, the presence of any Gram-negative bacterial species in
>> Water-for-Injection samples would be objectionable.
>>
>> Regards,
>> Don
>>
>> Donald J. English Microbiological Quality Consulting LLC Florham
>> Park, New Jersey 07932
>>
>>
>>
>>
>>
>>
>>
>> On Fri, Jul 17, 2020 at 7:35 AM Berman, Alison
>> <[log in to unmask]
>>>
>> wrote:
>>
>>> Hello,
>>>
>>> Is anyone performing chapter <60> testing at a sterile injectable
>>> manufacturing company, at any stage of manufacturing?
>>> Is there any reason one may do so and if yes, on what would the test
>>> be performed?
>>>
>>>
>>> Thanks
>>>
>>>
>>>
>>> Alison Berman, MFS
>>> Supervisor
>>> Quality Control - Microbiology
>>>
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