Evaluation Group / Evaluation Group 4 / This Evaluation Group / Consistency Testing Laboratory / /
Country
Canada / /
Event
FDA Phase / Product Recall / Product Issues / /
Facility
Publications Brooke Claxton Building / / /
IndustryTerm
validated manufacturing process / final product / test protocols / to biologic products / drug product / manufacturing process chemical complexity / blood products / health products / therapeutic product / manufacturing / alternate manufacturing process / drug substance chemical complexity / food / manufacturing process / /
MedicalCondition
disease / /
Organization
Health Products and Food Branch / Health Products and Food Branch THERAPEUTIC PRODUCTS DIRECTORATE / Biologics Evaluation Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics Certificate of Analysis Certified Product Information Document Clinical Trial Application Drug Identification Number Good Manufacturing Practices Human-derived Excipient Mutual Recognition Agreement New Drug Submission Notice / Therapeutic Products Directorate / Biologics and Genetic Therapies Directorate / Genetic Therapies Directorate Centre / /
Person
Lot Failure / Lot Release / DIN GMP HDE MRA NDS / / /
Position
Director / Minister of Health / Minister of Public Works / /
GUIDANCE FOR SPONSORS Lot Release Program for Schedule D (Biologic) Drugs Published by authority of the Minister of Health