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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:
Wed, 17 Jun 2020 10:51:04 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (411 lines)
Dear Franklin,



In regard to your idea of evaluating and establishing minimal competencies
of positions related to manufacturing processes in pharmaceutical
companies, I do not disagree.  It would be helpful, but the design and
implementation for such a program would be the problem



However, I’m not sure that ISO 17024:2012 would be applicable because it is
my understanding that it contains requirements for a body to certify
persons against specific requirements and includes the development and
maintenance of a certification scheme for persons. I still think that it is
the responsibility of the company to establish educational and experience
requirements and job responsibilities for each and every position.



The problem comes down to what are the common requirements and job
responsibilities for a position at one company to another company since
many people today are wearing many different hats due to cost and
head-count reductions.



For example, I was responsible at one time for supervising the R&D
Microbiology Laboratory but was also responsible for overseeing the Quality
Control Microbiology Laboratories at different manufacturing sites and
Quality Assurance auditors on a world-wide basis.  I found it to be very
interesting and stressful at times, but I did learn a lot and had fun in
overseeing the many different aspects of my position,


Regards,

Don


Donald J. English Microbiological Quality Consulting LLC

Florham Park, New Jersey 07932

On Wed, Jun 17, 2020 at 9:17 AM Franklin Binns <[log in to unmask]>
wrote:

> Dear Tony, Donald and Crystal,
>
> I really appreciate your feedback. In addition to my question and taking
> into account that each company has its own internal organization,  will you
> agree with the idea of evaluating and establishing minimal competencies
> related to manufacturing processes in pharmaceutical companies?
>
> For example, the person who is charge of the microbial counting, should at
> least know: to apply aseptic process techniques, to count correctly the
> UFCs, to validate growth media production, etc, etc
>
> Specifically, to develop schemes for pharmaceutical manufacturing job
> positions for a body that certificates people under ISO 17024?
>
> Franklin Binns
>
>
>
> El mar., 16 jun. 2020 a las 14:31, Crystal Booth (<
> [log in to unmask]>) escribió:
>
> > I agree with Don and Tony as well.
> >
> > -----Original Message-----
> > From: The Pharmaceutical Microbiology Forum Email List <
> > [log in to unmask]> On Behalf Of Donald English
> > Sent: Monday, June 15, 2020 3:39 PM
> > To: [log in to unmask]
> > Subject: Re: [PMFLIST] Standard for pharmaceutical manufacturing job
> > positions
> >
> > [CAUTION: This email originated from outside of the organization. Do not
> > click links or open attachments unless you recognize the sender and know
> > the content is safe.]
> >
> > 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
> > > >
> > > > ------------------
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> > > >
> > > > Steris -
> > > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww
> > > > .sterislifesciences.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7
> > > > Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2
> > > > %7C0%7C0%7C637278627635014104&amp;sdata=kRUDVQbeCV0QkNvrPR8tAeqhKFGl
> > > > zRY%2FoYh9tbIr2Wk%3D&amp;reserved=0
> > > >
> > > > Charles River Laboratories -
> > > > https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fww
> > > > w2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&amp;data=02%7C01%7Cc
> > > > booth%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d
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> > > > yFF0Owhx7%2F6VvECZneLsiUuaeXNCmTPNDBHM%3D&amp;reserved=0
> > > >
> > > > Veltek Associates, Inc -
> > > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww
> > > > .sterile.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e
> > > > 9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C
> > > > 637278627635014104&amp;sdata=ggG80P9mV%2BcAedGlHmCAsIi5k%2BP0dybOv9r
> > > > EjG%2B7CeE%3D&amp;reserved=0
> > > >
> > > > Microbiologics, Inc. -
> > > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww
> > > > .microbiologics.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefd
> > > > eab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0
> > > > %7C0%7C637278627635014104&amp;sdata=yxzsMUd9%2BazzfcbQsZEDSerQ%2FjMk
> > > > IQLEuTyaeV2KXtE%3D&amp;reserved=0
> > > >
> > > > BD Industrial Media -
> > > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww
> > > > .bd.com%2Fds%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e
> > > > 9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C
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> > > > 817jazg7P%2FvLW8%3D&amp;reserved=0
> > > >
> > > > Associates of Cape Cod, Inc. -
> > > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww
> > > > .acciusa.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e
> > > > 9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C
> > > > 637278627635014104&amp;sdata=1fZWZxsYkLa083jIwq56JW6tKNly9j7Ug9Cv35%
> > > > 2FWZ5o%3D&amp;reserved=0
> > > >
> > > >
> > > > =================================
> > > > 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.
> > > >
> > >
> > >
> > > --
> > > Tony Cundell, Ph. D.
> > > Consulting Microbiologist
> > > Email: [log in to unmask]
> > > Phone: 914 725-3947
> > > Cell: 914 841-0074
> > >
> > > ------------------
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> > >
> > >
> > > Steris -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.s
> > > terislifesciences.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefd
> > > eab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7
> > > C0%7C637278627635014104&amp;sdata=kRUDVQbeCV0QkNvrPR8tAeqhKFGlzRY%2FoY
> > > h9tbIr2Wk%3D&amp;reserved=0
> > >
> > > Charles River Laboratories -
> > > https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww2
> > > .criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&amp;data=02%7C01%7Ccboot
> > > h%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b
> > > 36f105d2b936dd2%7C0%7C0%7C637278627635014104&amp;sdata=p2mJ5cKyFF0Owhx
> > > 7%2F6VvECZneLsiUuaeXNCmTPNDBHM%3D&amp;reserved=0
> > >
> > > Veltek Associates, Inc -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.s
> > > terile.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741
> > > 062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278
> > > 627635024102&amp;sdata=xCbwDi5s5Ikofmf1jpaFw1PfgFeIu78WjB23WXqaJWc%3D&
> > > amp;reserved=0
> > >
> > > Microbiologics, Inc. -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.m
> > > icrobiologics.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab6
> > > 97e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7
> > > C637278627635024102&amp;sdata=8QntYuc2EL3wCeApJuny9Lf3C8QwHJtbjiYY%2FM
> > > 9fkrQ%3D&amp;reserved=0
> > >
> > > BD Industrial Media -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.b
> > > d.com%2Fds%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741
> > > 062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278
> > > 627635024102&amp;sdata=48Bl9ZK6AodEVx04hhvrahwLYDbzXenhJUo8x6DzefA%3D&
> > > amp;reserved=0
> > >
> > > Associates of Cape Cod, Inc. -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.a
> > > cciusa.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741
> > > 062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278
> > > 627635024102&amp;sdata=E3YtOspCP1zQtQeEAUQ6I3SUkVXN4hSjK0Kfn969aKE%3D&
> > > amp;reserved=0
> > >
> > >
> > > =================================
> > > 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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> > community.
> >
> > Please take a second to visit our sponsors' web sites and say thank you
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> > If your company would be interested in sponsoring this community, please
> > contact [log in to unmask]
> >
> >
> >
> > Steris -
> >
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterislifesciences.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278627635024102&amp;sdata=UwlZB1eBPkrlIrQS3B1SSSNKmK3L1Lrg2spPTX%2F%2FBt0%3D&amp;reserved=0
> >
> > Charles River Laboratories -
> >
> https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278627635024102&amp;sdata=Fly6vHjl8Be2ED2ZpI%2BfGnKERjhB3yXvS9Dkm2NcMRo%3D&amp;reserved=0
> >
> > Veltek Associates, Inc -
> >
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterile.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278627635024102&amp;sdata=xCbwDi5s5Ikofmf1jpaFw1PfgFeIu78WjB23WXqaJWc%3D&amp;reserved=0
> >
> > Microbiologics, Inc. -
> >
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.microbiologics.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278627635024102&amp;sdata=8QntYuc2EL3wCeApJuny9Lf3C8QwHJtbjiYY%2FM9fkrQ%3D&amp;reserved=0
> >
> > BD Industrial Media -
> >
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bd.com%2Fds%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278627635024102&amp;sdata=48Bl9ZK6AodEVx04hhvrahwLYDbzXenhJUo8x6DzefA%3D&amp;reserved=0
> >
> > Associates of Cape Cod, Inc. -
> >
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.acciusa.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C637278627635024102&amp;sdata=E3YtOspCP1zQtQeEAUQ6I3SUkVXN4hSjK0Kfn969aKE%3D&amp;reserved=0
> >
> >
> > =================================
> > 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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> > 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.
> >
>
> ------------------
> 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.
>

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