FDA Quality Initiative Inventory

FDA Quality Initiative Inventory

The following is an inventory of current focal points and related objectives of FDA's quality initiative prepared by CDER's compliance office.

? Validation - drafting of guidance document establishing risk-based life-cycle approach (draft due this calendar year)

? Part 11 - undertake rulemaking (proposed rule due this calendar year)

? Inspection prioritization risk-based model - evaluation and continuous improvement

? Pharmaceutical inspectorate - training, continued implementation, and Level III Certification

? Integration of CMC review and inspection - concept development and implementation

? Quality systems implementation for drug quality programs - starting with recalls, Wls, PAT, and PI

? PIC/S membership application - negotiate, initiate, and implement

? Q8 and Q9 guidance - complete guidance development and implementation

? Q10 guidance - initiate ICH process, complete, implement

? Quality systems guidance - finalize

? 314.70 and related guidances - revise to reduce manufacturing supplements

? GMP regulations - review to consider enhancements for harmonization and quality systems implementation

? 1996 proposed amendment to cGMP rule - withdraw

? 21 CFR Parts 210 and 211 - revise, modify (incremental approach)

? Dispute resolution - finalize guidance after evaluating pilot

? Science-based GMP guidance development - to incorporate into FDA inspectional oversight increasing process knowledge and risk-based approaches

? Preapproval compliance program - rewrite (due this calendar year)

? Combination products draft guidance - consideration of those comments