I will look into what are the industry standards for your product, time & resources available, what are your competitors doing & your own quality goals. (here assumption is that these documents are more concurrent and need is to convince the management with the advantages of moving towards that) Its about systems of typical ANDA drug product manufacturing company.(I was probably assuming that, since the selected sub group is for CFR 210-211 so the scope scope would be obvious)įurther, It certainly makes sense to improve towards better-robust-current system.,īut how do we establish the same need through objective assessment ' the need/advantages of moving towards either ICH Q10 or ISO 13485'. is aligned with current concepts/definitions of Quality by Design)Ģ) or to check, if its worthwhile the effort to align/upgrade the systems.ģ) Are there any literature/experiences available in this area?

(it includes, not only traveling in that direction, but also (if not inventing.)discovering it first! )ġ) what does it take to align CFR 210-211 based quality system to align with ICH Q10 (perception being that ICH Q10 being most current guidance.

And, I certainly have long a way to go in this direction.

Iso 13485 fda