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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 Jun 2020 17:11:04 -0500
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Franklin,
You have received excellent information from Don and Tony.  Also look at 
the requirements in the USP.  There are some excellent threads from the 
past that may give you some help on the PMF.


Please note in your job descriptions that you not only have USFDA 
concerns to meet, but you may also have other regulatory bodies that you 
must meet.  From the name of your company, I will assume that you are 
not within the US.  So please ensure to incorporate your labor standards 
requirements into your job description.   You may need to include the 
amount of walking, standing, sitting that will occur.  You may also need 
to include the amount of weight that should be carried by the 
individual.  These labor standards are not to discriminate, but rather 
set the standards that you are seeking for your company.  With standards 
today, you may expect a person to work 8 hours a day, 5, 6, or 7 days 
per week.  You may expect to  pay overtime for over a certain limit of 
hours.

My comment is only to think thoroughly through your job description:  
what are you testing and for whom?  what local and international 
requirements exist - DEA, FDA, ISO, radioactive, etc.  Ensure that your 
job description meets the requirements that you may find of a labor 
standard site or other google search.  Think about the types of 
individuals you want to have work for you.  Think about how much 
training that you wish to give these people when they come to work for 
you.  Remember that most universities do not teach industrial 
nomenclature, like normality, etc.

Hope that this information helps.

Good luck,
Courtland

courtland imel
ceo
Ceutical Laboratories, Inc.





On 2020-06-16 14:50, Crystal Booth wrote:
> 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
>> >
>> > ------------------
>> > 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 -
>> > 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
>> >
>> >
>> > =================================
>> > 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
>> 
>> ------------------
>> 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 -
>> 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.
>> 
> 
> ------------------
> 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 -
> 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.
> 
> ------------------
> 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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