Training Path - QA

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
1

Hi all,

since long I have been wondering what would be a reasonable training path for a person who is new in his role as a QA. I know that some of the topics one must learn are specific to the field in which the company, one is working, operates. Nonetheless, many other topics are pretty general topics.

In university and/or college you will not receive much or any education on the topics relevant to a QA role.

So I was thinking starting out with some basics like knowing what GMP, GDocP, etc is about would be a good start.

Then getting to know the relevant regulations but here already the question arises, how deep do you need to know the regulations ? Is it enough to know what each one is about and have a general overview of its contents, or do you require really deep knowledge about the content ? From there on, how would you proceed, so:

  1. Basic knowledge GMP, GDocP, Validation, etc
  2. Regulations (Deep knowledge vs knowing what its about)
  3. ?
  4. ?

I am really interested in your opinions and would be happy if we could have a good conversation / discussion on that.

Looking forward hearing from you!

2

Honestly. The biotech/pharma/device industry is interesting. With so many resources out there, you would think there would be a consensus, but in reality, there is a lot of ongoing discussion. I think the best way to approach being a QA person is to (a) know your own companies policies and procedures and (b) know where the industry is right now.

In order to get a beat on the industry, I would subscribe to a news feed and/or a FDA 483 and warning letter feed. It is important to know where other companies are getting in trouble and to avoid those things.

Warning letters are published as soon as they happen, but 483s can only be obtained through the Freedom of Information Act, and are not published just for publishing sake. So 483s are published by private companies who request the info from the FDA and then publish them (strange, I know).

Here are some resources for audit findings: I’m compiling a list of

3

And don’t forget the amazing courses we have online here:
http://learnaboutgmp.com/library/

For example our GMP and GDocP courses are been used by Merck and Mylan globally.

Regards

4

JaredCroft,

this is a very interesting approach, thanks a lot!

I am wondering though if focusing on the FDAs current findings (Warning Letters and 483s) might lead to not following the idealistic approach of really trying to build quality into your system(s) but instead just complying with regulations ?

Because what I found during my career is that there are roughly two kind of management types. Those who will follow regulations because they have to, but without understanding the value and real benefits of a good qms and those who really try to improve their quality system with conviction.

5

Burk-bn,

I understand what you are saying. But QA should never become the only line of defense for “quality being built into your system”. The best way for quality to be built into your system, is for QA to set expectations, train engineers, labs personnel, etc, so that everybody can be the eyes and ears of quality. QA should infuse a system and mentality of quality into a company. But they should also realize that often the lab personnel or engineers (for example) are better suited to design a process that is robust and reliable (following QbD principles).

Asking QA to build quality into your systems is too short-sighted. The reason that I reference FDA’s findings is because a company can easily get lost in their own internal SOPs and issues, without considering where the industry is going. Gaining information from the industry can balance what you “already know”. In my experience QA that only knows one company’s policies can miss deficiencies and gaps.

So no. I’m not suggesting that you check into compliance or just focus on passing regulations. (That would be similar to testing into compliance). Instead I’m suggesting that you take a wholistic approach and learn from other’s mistakes, so that you don’t repeat them.

1 Like
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JaredCroft,

I can see your point and think that what you described is a logical and well-thought approach to building a robust quality system. Thank you for sharing your experience and letting me learn from it.

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You’re welcome, and good luck!!