Informations request

Quality Assurance
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hi everyone i hope you are doing well,

I have experience in microbiology, however I would like to jump to quality assurance, I am reading and documenting myself on this, I am stuck on change control and the annual quality review, I seek your help.
another thing, for the ICH Q9 risk analysis, is this a general procedure? or for example, for each production line, we will have to carry out a risk analysis procedure to, for example, identify the critical points and be proactive to avoid any problem or, for example, to define the critical points for air sampling.

your help will be greatly appreciated.

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Risk analysis should be done for all critical processes, where there may be a risk to the quality of the product.

2 Likes
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So, as there are several risks in the different production lines, do we do a risk analysis for each line? for example by FMECA ?
Thank you

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