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Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.

PB2014107379

Publication Date	2014
Page Count	16
Abstract	This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that we have determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report. Appendix A lists examples of CMC postapproval manufacturing changes previously submitted under manufacturing supplements that we have determined generally to be of low risk to product quality. Appendix B provides examples of minor changes to be documented in an annual report that were previously published in FDA's Scale-up and Postapproval Changes (SUPAC) guidances and other postapproval change CMC guidances (see Section V. Resources for a list of those guidances).
Keywords	Industry guidance Drugs Annual reports Applications Chemistry Documents Manufacturing Process changes Product quality Postapproval changes Chemistry Manufacturing and Controls(CMC) New drug applications(NDAs) Center for Drug Evaluation and Research(CDER)
Source Agency	Food and Drug Administration
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Drug Evaluation and Research.
Document Type	Technical Report
NTIS Issue Number	201420

Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.

Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.
PB2014107379

Publication Date	2014
Page Count	16
Abstract	This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that we have determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report. Appendix A lists examples of CMC postapproval manufacturing changes previously submitted under manufacturing supplements that we have determined generally to be of low risk to product quality. Appendix B provides examples of minor changes to be documented in an annual report that were previously published in FDA's Scale-up and Postapproval Changes (SUPAC) guidances and other postapproval change CMC guidances (see Section V. Resources for a list of those guidances).
Keywords	Industry guidance Drugs Annual reports Applications Chemistry Documents Manufacturing Process changes Product quality Postapproval changes Chemistry Manufacturing and Controls(CMC) New drug applications(NDAs) Center for Drug Evaluation and Research(CDER)
Source Agency	Food and Drug Administration
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Drug Evaluation and Research.
Document Type	Technical Report
NTIS Issue Number	201420