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21 CFR part 111 & 110

thread286-388419

21 CFR part 111 & 110

21 CFR part 111 & 110

(OP)
Hey there
Have two questions would like to share with you and looking forward to share your thoughts on this

1- Are dietrary supplements required by 21 CFR parts 111 and 110 to have a change control SOP? I know 211 and 210 does require that but supplements do require change control SOP?

2- Suppose the answer to the first question is YES- Do we have to mention in the SOP that anytime we are revising a SOP we will make a change control?

Thank you


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