Changes Being Effected

CBE "Supplement-Changes Being Effected" supplement submission for certain moderate changes for which distribution can occur when FDA receives the supplement as provided in 21 CFR 314.70 and 21 CFR 601.12. 

Filing documentation—A supplement should be hied showing the changes being effected. Long-term stability test data should be included in the annual report. 

Filing documentation required—Changes being effected should be identihed in a supplement. Long-term stability data are reported in the annual report. 

Supplement Changes Being Effected (CBE) in 30 Days For a moderate change (moderate potential to have effect on quality and performance), a supplement has to be submitted to the FDA for approval 30 days before a product made with the change is distributed. 

Changes being effected supplement (accelerated stability data for MR and no stability data for IR) Annual report (longterm stability data for MR and IR)... 

Prior approval supplement (accelerated stability data) for MR and changes being effected supplement forIR... 

A changes being effected (CBE), CBE in 30 days (CBE-30), or prior approval (PAS) supplement can be submitted to the agency prior to implementation, and, if necessary, an inspection can be performed by a PAT team or PAT-certilied investigator before implementation. 

Changes being effected supplement annual report (long-term stability test data). 

Stability One batch with three months accelerated stability data reported in Changes Being Effected supplement and long-term stability data of first production batch reported in annual report. 

Changes Being Effected supplement (all infonnation including accelerated stabil-... 

I. Chemistry Documentation. Application/compendial product release requirements. Notification of change and submission of updated executed batch records. Significant body of information available One batch with three months accelerated stability data reported in changes being effected supplement and long-term stability data of first production batch reported in annual report. 

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