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Organization change - how to handle it in GxP environment?

Updated: Nov 10, 2023

Organization change is always fashionable. 'Let's start to centralize', 'Let's start to decentralize', 'Let's dedicate a team'. There may be some upsides to these changes, there are much more prepared experts to tell their opinion, I don't plan to argue this.


However, from quality point of view, there is a risk related to every organization change in GxP environment. What kind of risk you ask? the Responsibility kind.


What does ICH Q10 say (Section 2.1 (b)(4) ) about management commitment?


'Define individual and collective roles, responsibilities, authorities and inter-relationships of all organisational units related to the pharmaceutical quality system. Ensure these interactions are communicated and understood at all levels of the organisation. [...]'


So this part may be missed, if management is too enthusiastic on an organizational change.

As QA, you have to be calm, objective, and you need to be sure at all times, who is responsible for what in your quality system.

I'm not saying you need a formal change control to evaluate (actually, I would advise against that), but you may want to develop a tool to follow-up the involved departments' GxP-responsibilities handover-takeover before the change is actually implemented. You should also check your procedures to update, user accounts to reconsider, but you will get to know all of these derived from your evaluation tool.



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