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June 2020

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 Jun 2020 11:19:18 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (90 lines)
The US Federal GMP regulations 21 CFR 211.25 Personnel Qualifications (a)
 states " Each person engaged in the manufacture, processing, packing or
holding of a drug product shall have education, training and experience or
any combination thereof to enable that person to perform the assigned
functions"

A company must have job descriptions for each GMP position and the names,
CV and GMP training records of each employee would be maintained and
available for inspection.

On Mon, Jun 15, 2020 at 10:47 AM Franklin Binns <[log in to unmask]>
wrote:

> Dear Experts,
>
> Do you know if there is a standard (i.e. ISO, ASTM, etc, etc) that
> describes job positions in pharmaceutical industry?
>
> For example, for a quality control analyst for medications or for a
> production quality inspector? A standard that describes the minimum
> competencies, skills and knowledge for that job position?
>
> Franklin Binns
> CEO
> Microbiología farmacéutica
>
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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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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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