Bioequivalence and Bioavailability Forum

Hi Pandu,

❝ I need clarification on Training of SOPs. My department (PK-stats) persons prepared SOPS and signed off the same. When I am raising the request for training, other department (clinical and analytical) persons are also interested to attendant the training. But in there JD's our sops were not mentioned (our sops are not related to there work).

By all means, do the training, also for those who are interested but not directly involved.
There more the "unrelated" people understand about processes in other departments, the better they will understand how their own function impacts the downstream activity, and it will also help them propose relevant changes to the system.
I would not in any way shy away from training them. In fact, I think you are privileged that colleagues from other functions express this interest. Cease the moment.

❝ Is it Ok for providing training for all the persons, it approved by regulators. If yes how to document for this.

A BE study is principally a study on rate and extent of absorption. Everything everyone does in such an organization is centered on ethical production of credible data for exactly that. Why on earth would it be an issue to train them?

❝ If SOP version changes or revised again we have to give training for all these persons?

That need should be determined by your own QMS. I am leaning towards only re-training those who work directly under the procedure, when it changes. The others on ad-hoc basis.

I like this post.