"As a professional involved with GMP regulations and compliance for over 30 years, I know firsthand the challenges of staying current with global regulations and compliance expectations. One tool which can provide assistance in this area is the GMP MANUAL. This reference is available in either hard copy or electronic form. Contained within the manual are the regulations and guidelines from various regions and regulatory bodies around the world (Europe, Japan and the United States; ICH, PIC/S and WHO). In addition, there are a number of chapters which cover the GMP-related topics encountered every day, with suggestions on ways to address these topics. The content of the GMP MANUAL is reviewed by an international advisory board to help ensure it remains up-to-date and accurate. It is updated on a regular basis. The GMP MANUAL occupies a spot in my bookcase and I often have the occasion to refer to it. If you are a professional in the field of GMP and regulatory compliance, you may find it should be in your bookcase too."

Bob Dana
Senior Vice President, Regulatory Affairs
and PDA Training and Research Institute

“It is a great idea and I use it all the time. I like the objectives at the beginning of each session and the straight forward information. It really is a fantastic and great tool. It is easy to update and it is one of my best investment.”

Janice B. Wilson, PH. D.
The Biologics Consulting Group, USA

“We are very satisfied with the GMP MANUAL and like the tracability matrix of the inspection checklist and the clear references to the different regulations. We are in a global market and the GMP MANUAL addresses all the most important regulations. It is a very good starting material to explore more.”

Francois Rousseau
Merial Ltd., Canada

“This is an excellent reference work. It covers nearly all the important topics within GMP and has the flexibility to grow over time. All subjects are dealt with logically and in great detail. The use of checklists, examples and hyperlinks to related topics are particularly good.
[…] this is an excellent investment for both practitioners and
trainers. I will certainly be using it extensively.”

Dr. Kate E. McCormick
Heathside Information Service Ltd., GB

“The GMP MANUAL is a highly interesting project and I am honored to be able to support this project with my knowledge. With the GMP MANUAL we are in a position to initiate discussions on different approaches to regulatory requirements and the various possibilities to comply with these (GMP) regulations on an international level.
We should outline different interpretations and their possible solutions by offering reasonable standards for the industry.”

Dr. Lothar Hartmann
F.Hoffmann-La Roche Ltd., Basel, Switzerland, Chair of the Advisory Board

“My group and I have found the GMP MANUAL very helpful for the following reasons:
The material is very well organized and complete; you don’t necessarily have to go to other reference material.
It is catalogued in such a manner that enables it to be used as a training tool for my auditors.
The content is well researched, gives you information on topics such as FMEA, and RCA etc.

I used the GMP MANUAL in my dissertation “Noncompliance in the pharmaceutical industry: A phenomenological study.” ”

Dr. Pathak
Endo Pharmaceutical, USA