Manufacturing changes

Chemistry, Manufacturing, and Controls Supplement = manufacturing change supplement submissions as provided in 21 CFR314.70,21 CFR314.71,21 CFR314.72 and21 CFR 601.12 ... 

REASON FOR SUBMISSION This section should contain a brief explanation of the submission, e.g., "manufacturing change from roller bottle to cell factory" or "response to Information Request Letter of 1/9/97" or "Pediatric exclusivity determination request" or "to satisfy a subpart H postmarketing commitment". 

Exposure-response data, however, are not likely to obviate the need for clinical data when formulation or manufacturing changes result in altered PKs, unless the relationships between measured responses and relevant clinical outcomes are well understood. The sponsors of studies need to make a financial evaluation of these studies as well often. 

Adds a provision that is intended to reduce the number of post-market manufacturing changes requiring FDA approval and otherwise to make it easier to implement manufacturing changes for approved new drugs. 

Manufacturing process modification Document manufacturing changes in annual reports Approval required for every manufacturing change before implementation Submit manufacturing changes and vahdation documents to FDA 30 days prior to product distribution"... 

Waiver of in vivo bioequivalence studies for major post approval manufacturing changes for the BCS Class I (Biopharmaceutics Classification System highly soluble, highly permeable and rapidly dissolving) solid oral products is NOT recommended for narrow therapeutic index drugs (17). 

Manufacturing Manufacturing changes may be either the equipment used in the... 

For the past several years, scientific debates within the pharmaceutical community on the topic of manufacturing changes have centered on the question of additional tests and reporting requirements needed to document unchanged quality and performance. The SUP AC approach focused this debate on the definitions of significant changes and what constitutes sufficient characterization. 

Manufacturing changes Scale-up of a developmental product using encapsulation equipment of different design. 

The discussion to follow examines the SUPAC-IR guidance recommendations for the manufacturing changes encountered in the selected example. Although this guidance did not provide recommendations on multiple related changes, the new guidance [10] does address this issue as follows ... 

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