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Subject:
From:
Greg Birrer <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 17 Jun 2020 13:39:11 +0000
Content-Type:
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Hi Franklin,
With respect to manufacturing job descriptions there are 2 general ways to go about it.  One is to state generalities about the expectations of what the GMP operators should have, i.e., appropriate education, training, & experience.  This leaves it up to the firm to decide which employees can perform certain duties (as long as they can show the employee has an adequate combination of the 3).
The other way is to lay down a guidance document to specify what is needed for various GMP positions.  This route that will lead ever increasing detail as to what must be met to do certain jobs.  This eventually leads to full certification, and an accreditation service.  Then the emphasis becomes taking courses to gain certifications outside of the company and only those with certifications may take on new positions.  In this scenario I fear that employees with years of excellent experience or that for any reason would not be able to gain certification might be overlooked.  Manufacturing firms are incentivized to get the right people in the right jobs.  Let's let them work it out and avoid more regulation.
Cheers,
Greg Birrer

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Franklin Binns
Sent: Wednesday, June 17, 2020 7:04 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Standard for pharmaceutical manufacturing job positions

CAUTION: External Email

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%2Fw
> > > ww
> > > .sterislifesciences.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM
> > > %7
> > > Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936d
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> > > Gl
> > > zRY%2FoYh9tbIr2Wk%3D&amp;reserved=0
> > >
> > > Charles River Laboratories -
> > > https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2F
> > > ww
> > > w2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&amp;data=02%7C01%7
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> > > Microbiologics, Inc. -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fw
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> > > BD Industrial Media -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fw
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> > > .bd.com%2Fds%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab69
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> > > Associates of Cape Cod, Inc. -
> > > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fw
> > > ww
> > > .acciusa.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab69
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> > >
> > > =================================
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> > >
> >
> >
> > --
> > 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%7Ce
> > fd
> > eab697e9741062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0
> > %7
> > C0%7C637278627635014104&amp;sdata=kRUDVQbeCV0QkNvrPR8tAeqhKFGlzRY%2F
> > oY
> > h9tbIr2Wk%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%7Ccbo
> > ot
> > h%40BIOTECH.COM%7Cefdeab697e9741062cdc08d811890cb9%7C601248d078d24b7
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> > hx
> > 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%7Cefdeab697e97
> > 41
> > 062cdc08d811890cb9%7C601248d078d24b79b36f105d2b936dd2%7C0%7C0%7C6372
> > 78
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> > D&
> > 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%7Cefdea
> > b6
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> > FM
> > 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%7Cefdeab697e97
> > 41
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> > Associates of Cape Cod, Inc. -
> > https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww
> > .a
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> > 41
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> > amp;reserved=0
> >
> >
> > =================================
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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
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>
> Charles River Laboratories -
> https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww2
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> 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
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> Microbiologics, Inc. -
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.m
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> BD Industrial Media -
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.b
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> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.a
> cciusa.com%2F&amp;data=02%7C01%7Ccbooth%40BIOTECH.COM%7Cefdeab697e9741
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> amp;reserved=0
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>
> =================================
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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.
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>

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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/


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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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