Fady,

I have worked in the past at a fairly large pharma, which had a very thorough QMS system. Advantage of this, is that everything is kind of well characterized, drawback, a lot of paperwork to shift through during training.

I have also worked at a small start-up, nutraceutical, and was there during the actual QMS setup phase. In order to start production as soon as possible, QMS was bare bones, in many instances almost non-existent. But they were making changes to it as the problems came about, even making changes to methods upon how to make changes. Now the advantage they had was it was quick implementation, and changes, due to the whole QA department consisting of 2 people. All they did was churn out SOPs all day long, and got paid very handsomely for it. But I feel if this company were to be audited by the FDA, I’m pretty sure the outcome wouldn’t be great.