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June 2020

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Subject:
From:
Crystal Booth <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 Jun 2020 19:50:13 +0000
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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
> > 24b79b36f105d2b936dd2%7C0%7C0%7C637278627635014104&amp;sdata=p2mJ5cK
> > 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
> > 637278627635014104&amp;sdata=FEM%2BkD7qxN%2FVruza0%2BBzod%2FIdc%2BuG
> > 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
> >
> >
> > =================================
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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 
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> please contact [log in to unmask]
>
>
>
> 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
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> 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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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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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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