about

We do what you do- GMP Compliance Basis is produced by people who work in your industry;
professionals with experience with architecture, engineering, validation and operational
experience in the pharmaceutical and biotechnology industry.

Project Execution Basis- Years of experience with complex project types and all aspects of
project execution and operations experience associated with GMP compliant facilities have
provided the backdrop for the information you see presented here.

Our own experience- We have dealt extensively with the engineering and compliance issues
faced in this industry. Our own efforts in seeking an organized and integrated solution have
resulted in the development of the CB Operating System.

Contact us- Feel free to contact GMP CB should you have any questions or require any
additional information.
Better yet, stop by our blog!!!

What are we trying to accomplish???- It's pretty basic...
We had our own questions about the whole Commissioning & Qualification issues....the more
we asked questions the more it became apparent there was not a coherent overall
explanation...
The "V Model"...the "W Model"... GAMP...Validation Plans, Commissioning Plans, etc, etc, etc...
all good stuff...but who could explain how it was all supposed to work together over the course
of a project...

Implementation- We also didn't see this approach being actually implemented on
projects...talked about, yes... presented to clients, yes...but never actually fully implemented,
maybe portions of the approach, but not the whole concept. This leads to another
question...How would you implement the entire effort, as a system?
Procedures, Checklists...all of it...

We are seeking our own answers...
to our own questions...
this web site documents how far we've gotten to date...

Feedback- Let us know if you agree, disagree, whatever...
it can only help advance the discussion...