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June 2020

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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 Jun 2020 15:39:13 -0400
Content-Type:
text/plain
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Dear Franklin,

Tony is correct that 21 CFR 211.25 indicates that every person should have
the education, training and experience or
any combination thereof to enable that person to perform the assigned
functions.

From my experience, I have never seen a standard from either ISO, ASTM or
any other organization that describes job functions and responsibilities in
the manufacturing of drug product formulations.  A probable reason for why
there is no standard for job descriptions
is that job responsibilities for a position can vary from company to
company based upon organizational structure, type of manufacturing (e.g.
sterile vs. non-sterile) and assigned daily tasks

Job descriptions for positions that are involved in the manufacturing of
drug products is usually the responsibility of the hiring manufacturer of
the company to establish by writing.  In these job descriptions, there are
often paragraphs indicating educational and experience requirements for
a person to hold that position and a description of daily
responsibilities.   In addition, it is also usually the responsibility of
the hiring manager to establish a training record in the functions and
tasks for each individual that they are responsible for supervising and to
keep these training records up-to-date on a year basis.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932


On Mon, Jun 15, 2020 at 11:29 AM Tony Cundell <[log in to unmask]> wrote:

> 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
> >
> > ------------------
> > The PMFList is supported by our sponsors as a service to the scientific
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> > 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
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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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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.
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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/


=================================
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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