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Pharmaceutical sciences / Medicine / Health / Food and Drug Administration / Quality by Design / Good manufacturing practice / Quality management system / Corrective and preventive action / Title 21 of the Code of Federal Regulations / Quality / Pharmaceutical industry / Pharmaceuticals policy


Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Health and Human Services Food and Drug Administration
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Company

Quality Management Systems / MODERN QUALITY SYSTEMS / /

Country

United States / /

Event

Product Issues / /

Facility

Rockville Pike / /

IndustryTerm

manufacturing changes / pharmaceutical product / pharmaceuticals / pharmaceutical regulatory systems / medical products / manufacturing world / manufacturing personnel / manufacturing technologies / defective products / drug manufacturing process / quality systems / drug manufacturing / pharmaceutical manufacturing / manufacturing science / biological drug products / risk management / manufacturing / manufacturing operations / manufacturing human / biologic-device combination products / highquality drug product / manufacturing practice / risk management tools / active pharmaceutical ingredients / pharmaceutical products / pharmaceutical manufacturers / drug products / manufacturing problems / manufacturing processes / manufacturing process / /

Organization

U.S. Department of Health and Human Services / Training and Communication Division of Drug Information / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Center for Veterinary Medicine Food and Drug Administration / office of Compliance / office of Regulatory Affairs / D. Organization / office of Training / HFD-240 Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / Center for Veterinary Medicine / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / Environmental Protection Agency / office of Communication / Training and Manufacturers Assistance / /

Person

Fishers Lane Rockville / /

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Product

products / /

ProvinceOrState

Maryland / /

Technology

drug development / /

URL

http /

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