Hi All,

Yes, I agree that the ambiguity of GMPs makes it difficult for startup organizations to find the right way to implement them. When I worked in a small organization, We always struggled to understand what should be done. We spent so much money on training and consulting firms to make sure that we understand the regulation correctly and we implement it properly. There were times that we struggled because some of the regulation sections did not apply to us and we were struggling about how would we justify that without falling into the trap of being out of compliance. On the other hand, I also believe that there is an upside for the vagueness of GMPs. This allows for room of interpretation and innovation in application of GMPs. The regulators wanted to leave organizations with some leeway to implement what they understand as long as they are not out of compliance.