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Is cGMP Training Mandatory?

E

eileenr

#1
#1
Hello Everyone
I have a queries regarding cGMP training, in all FDA regulated environments I have worked in, it was mandatory to receive cGMP training yearly. I have been asked by a colleague to show me where in the medical device standard it stipulates this, and although there is a section 820.25 (b) Training: Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
My question is this, is there anywhere in the guidelines that states that cGMP must be given yearly or is this a method that quality people use to have evidence that their employees are being trained.
Thanks for any feedback
Much appreciated
E
 
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Ajit Basrur

Ajit Basrur

Staff member
Admin
#2
#2
eileenr said:
Hello Everyone
I have a queries regarding cGMP training, in all FDA regulated environments I have worked in, it was mandatory to receive cGMP training yearly. I have been asked by a colleague to show me where in the medical device standard it stipulates this, and although there is a section 820.25 (b) Training: Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
My question is this, is there anywhere in the guidelines that states that cGMP must be given yearly or is this a method that quality people use to have evidence that their employees are being trained.
Thanks for any feedback
Much appreciated
E
Click to expand...
Hi E,

There is a reference from 21 CFR Part 211.25 - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.25.

Per the highlighted text, Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis, the industry best practise is to conduct training on an annual basis.

Sec. 211.25 Personnel qualifications.
(a) 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. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
 
E

eileenr

#4
#4
Hello Ajit and Doug
That is exactly what I needed thank you. I knew that cGMP training needed to be given but I needed to find out where it was documented. Ye will make a decent Quality Engineer of me yet!!!!
Regards
E:bigwave:
 
sagai

sagai

Quite Involved in Discussions
#5
#5
Word of caution, that is for pharmaceuticals!

Teaching all staff about legislation as a mandatory training sounds bizarre for me to be honest.
However for regulatory guys and for quality (not quality control though!) guys it is inevitable.

Cheers!
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#6
#6
Agree Doug and Agai.

Yes its for Pharmaceuticals but as mentioned, an annual cGMP training is extended by med device manufacturers to all employees as a best practise.

We do in our facilities too.
 
sagai

sagai

Quite Involved in Discussions
#7
#7
Sorry for hanging on this ... I do not get it and I would like to understand.

Is this training is about to teach the corresponding part of the legislation/law for all staff? What is the benefit of it rather than having company specific QMS training?
And I really do not know where does the credential coming to consider it best industry practise.

Could be a case that I have misunderstood something though.

Regards
 
D

Doug Tropf

Quite Involved in Discussions
#8
#8
Ajit Basrur said:
Agree Doug and Agai.

Yes its for Pharmaceuticals but as mentioned, an annual cGMP training is extended by med device manufacturers to all employees as a best practise.

We do in our facilities too.
Click to expand...
Might be a good practice to provide cGMP training but as far as I know it is not a requirement.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#10
#10
I think it is a bit of a relic.

Today, in FDA terminology cGMP equals QSR. However, the original GMP consept far predates the QSR. In ancient times (I guess up until the 1960s or so) control of pharmaceutical production environments was very limited. After some high profile incidents, the first GMP measures were introduced - mostly dealing with the prevention of contamination / cross-contamination / otherwise adulteration of medicinal products in the production environment. Over the years GMP has evolved and expanded to cover more and more topics, until the introduction of the QSR in 1996, at which time the GMP best practices were integrated in the QSR as "cGMP" (c for current).

For the medical devices industry GMP (how to "properly behave" on the production line) is mostly perceived as a subset of the QSR, but I think the pharma industry still "remembers" it from old times as something separate, and due to strong and effective enforrcement in the pre-QSR years (which is, BTW, considered to have had a dramatic effect on industrially manufactured drug safety) still "feels" obliged to strongly and routinely "educate" production line employees to that particular set of practices.

I think that in the modern medical devices manufacturing environment cGMP training is an inseparable part of QMS-related training and there's no real reason for treating it separately / differently from other QMS aspects. The specifics of training content, audience, frequency etc. should be determined based on a rational analysis, and captured in the company's training procedures and practices. cGMP training should be viewed as any other training towards implemetation of / compliance with the QMS procedures.

Just my opinion.

Cheers,
Ronen.
 
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