GMP Training Materials Required
Hi Everyone,
I am new to this community. Am interested in GMP of pharmaceuticals.
It will be helpful for me if someone could share an idea where I can get CGMP training/webinar/material etc.
Expecting some valuable ideas/materials.
Thanking you all in advance.
9 Replies
I suggest you start with the ASQ Pharmaceutical GMP Professional Handbook, H1386, or the current second edition H1511.

You can also review items in the Body of Knowledge for the exam. Additionally, the drug section of FDA has training related materials.
I am also a member of SQA and actually will be attending a Quality College course on GMP Fundamentals next week for two days. The course will be available later on for purchase. SQA’s work is specializes in human and animal pharmaceuticals. Hope this helps.
kind regards
I am currently in the process of studying for CPMP. In addition to buying ASQ book, I recommend purchasing the following books:

- Eudralex Volume 4 - Good Manufacturing Practice Guidelines
- ICH Quality Guidelines

I also have been printing a lot of FDA guidance materials primarily referenced material through ASQ sample questions and putting these into a 3-ring binder.
Wonder if you've details of the
SQA Quality College course on GMP Fundamentals.

I am leading a virtual workshop on excipient GMP auditing in 2 weeks. You can get details at
Harischandran - Thanks for asking the question. All of the replies are good. It is an open book test, so you will be able to take bound material in with you to the test. A couple of other suggestions. Getting the "ASQ Certified Pharmaceutical GMP Professional Question Bank" is well worth it to understand the style of questions. Also the FDA has many official "Guidance Documents" that are informative, "Quality Systems Approach to Pharmaceutical cGMP Regulations" and "Investigating Out-of-Specification Results" is another. FDA has over 50 of these documents on drug cGMPs at no charge.
A lot depends on your goal for GMP materials. Is it to study for the CPGP exam or to learn basic GMPs. Either way just learning the regs / guidance is only part of the process. You need to understand the background of the GMPs, why are they there, and more importantly how do I apply them on a day to day basis. While open book, the CPGP test still requires you to both know certain aspects of GMPs (e.g. which of the following is not included in the GMPs) as well as being able to apply the regulations/guidance in a practical setting.

I have a webinar Fundamentals of GMP, developing a compliance mindset. Its available for delivery for anyone that is interested as well as numerous others you can find on my website ( Email me at for more info.
Deal fellow members,

I am from Canada. Touching the same topic of studying for cGMP. Is there any initiative from ASQ worldwide to organize a study group for this certification?

Could I suggest to pass on this request to your local divisions? We live now in a virtual world and it is doable.

FYI - here is Toronto for now there is none

Please let me know,

Please contact Toronto section for study group.