cGMP Certification

7 Replies

cGMP Certification

Posted by Ashok Chauhan on Nov 28, 2018 10:16 am

Hi All,

I need some guidance on cGMP certification. I don't have pharma/medical industry experience. I am from automotive background but I am very much interested in pharma/medical industry. 

I gave the exam in June, 2018 but didn't pass. I ordered "The Certified Pharmaceutical GMP Professional Handbook, Second Edition" & ASQ question bank to prepare for the exam but I found questions to be difficult and I felt the questions were not part of the book I ordered or question bank.

I am planning to retake the exam. Based upon my first experience, I am not sure about the right study material to prepare for the certification. Could someone please guide?

Thanks,

Re: cGMP Certification

Posted by Amanda Foster on Nov 29, 2018 1:06 pm

Wow, that's disconcerting! I have used the handbook and question bank for another certification and felt they really helped my prepare for the exam. That's pretty disappointing. There is always a list of recommended study materials on the certification information page. I guess I would start there. Did you give ASQ feedback on your experience with the exam? Maybe they have some insight for you.

https://asq.org/cert/pharmaceutical-gmp
Amanda Foster, ASQ CQA

Re: cGMP Certification

Posted by Stephanie Gaulding on Nov 29, 2018 2:01 pm

Hi Ashok,

As someone who works in the Pharmaceutical industry, I can understand why you found the practice bank and exam questions difficult. The Body of Knowledge (BOK) for this certification is pretty big and you will have a disadvantage having not working in the industry to gain first hand knowledge in these areas. This is not a certification that you can rely on just the handbook and the question bank to pass. When I took this exam, I not only had the handbook but also a pretty significant stack of printed references from the reference list (think it was something like 6 inches tall). I remember spending more time in the references I brought than the handbook to answer the questions I didn't know.

I agree with Amanda that you need to review some of the other reference material listed (CPGP References - https://asq.org/cert/pharmaceutical-gmp/references). As you will see from this list, the number of references, in addition to the handbook, that the exam is based on is long. The good news is that over 90% of these are available free of charge from the various regulatory and pharmaceutical related professional societies. The challenge for you will be that the exam questions (both from the bank and the actual exam) can come from any of these additional reference sources or the handbook.

Since you haven't worked in the industry, I would recommend reviewing these additional references and determine which you feel comfortable that you know the content and which you may want to bring with you to the exam. I would focus on the 90% that are freely available as they cover a large portion of the BOK. This may mean it may take a few months (or more depending on time you have available) to prepare to retake the exam. It is also important to keep in mind that these questions are not going to be just memory checks as the exam questions are written to the Bloom's taxonomy level identified in the BOK (https://p.widencdn.net/uu66jp/40179_CPGP_Cert_Insert). When you look over the BOK, pay attention to the Bloom's taxonomy level. You'll find most of this BOK is tested at apply, analyze or evaluate level which means not only reading the materials but being able to use the concepts described in the references to answer the questions will be important. This is likely why you found this certification challenging as you haven't had the opportunity to learn and apply this knowledge in your "day" job. 

I'll be honest, based on my experience with the exam, it is not one I would recommend to people who haven't work in the pharmaceutical industry for at least a couple of years. I'm not saying you can't pass the exam unless you have worked in the industry but the knowledge you have to gain is pretty significant in order to get there.

One other idea might be to post a question looking for others in a similar boat as you are and pose forming an in-person or virtual study group.

Hope this helps and feel free to reach out to me if you have questions on my response.

Kind regards,

Stephanie



 
Stephanie Gaulding, CQA, CPGP, Chair-Elect Human Development & Leadership Division and Director of Regulatory Compliance @ Pharmatech Associates, Inc.

Re: cGMP Certification

Posted by Amanda Foster on Nov 30, 2018 8:02 am

Stephanie Gaulding‍ great advice! I wondered it lack of hands-on experience was a great impediment for this BOK. I know it is a highly regulated field.
Amanda Foster, ASQ CQA

Re: cGMP Certification

Posted by Paolo Rota on Nov 18, 2019 3:52 pm

Hi Ashok,

Were you able to pass the exam?
I have mine in December 2019 and am experiencing similar challenges.
What would be your tips for the exam? Are the questions sorted similarly to the BoK or are they randomly sorted?
Do you have enough time to answer the 175 questions?

Kind regards,
Paolo 

Re: cGMP Certification

Posted by Stephanie Gaulding on Nov 18, 2019 4:39 pm

Hi Paolo,

For test-taking tips, I'd recommend reading through this thread: https://my.asq.org/discuss/viewtopic/39/571?post_id=1744#p1744

The questions in the actual exam will be randomly ordered. 

I've been working in the Pharma industry for 25 years and I only had about 20-30 min to spare. As I discussed below, the biggest challenge with this certification is the breadth of the body of knowledge.

Feel free to reach out to me directly if you have more questions.

Kind regards,

Stephanie
Stephanie Gaulding, CQA, CPGP, Chair-Elect Human Development & Leadership Division and Director of Regulatory Compliance @ Pharmatech Associates, Inc.

Re: cGMP Certification

Posted by Jeremiah Genest on Nov 20, 2019 5:29 pm

The work experience requirement is"Candidates must have five years of on-the-job experience in one or more of the areas of the Certified Pharmaceutical GMP Professional Body of Knowledge. A minimum of three years of this experience must be in a decision-making position. "Decision-making" is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions."

Frankly, you should not have been allowed to take the exam. I'll be honest, this body of knowledge requires hands-on-experience. It is not entry level. In my experience there are people with 20 years of experience who have not touched every area of the body of knowledge, and have struggled with the exam.

This is like taking six sigma master black belt and never having been on a black belt project.

Jeremiah

Re: cGMP Certification

Posted by Stephanie Gaulding on Nov 20, 2019 5:46 pm

Hi Jeremiah,

You raise very similar points to what I do when I speak with people about this I exam. It is not an entry level certification and is not designed for someone who has never worked in the pharmaceutical industry (thus the experience requirements). People who haven’t worked in this industry don’t understand the complexity of the requirements or how to interpret them. They just don’t have the experience to help them with the higher level questions (using Bloom’s taxonomy). 

I’ve encountered a lot a folks who think this is a certification that will help them to transfer into the pharmaceutical industry. It’s actually the opposite. It recognizes knowledge and experience of a seasoned pharmaceutical professional. You’re also completely right, a person can work in Pharma but not gain experience across all the areas of the CPGP BOK even when working in a quality position.

I’m not sure what the process is to verify the experience requirements as part of applying for a certification exam but I’m going to ask about that...you’ve made me curious!

And I love you’re analogy! I may start using it to try and help people I talk with understand, if you don’t mind. :)

Stephanie

 
Stephanie Gaulding, CQA, CPGP, Chair-Elect Human Development & Leadership Division and Director of Regulatory Compliance @ Pharmatech Associates, Inc.