Production and Process Controls: Overview of CGMP Regulations and Regulatory Expectations – PDF Download

Manostaxx
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Manufacturers
 Manage reliable and secure supply chain
 Maintain risk mitigated, reliable, and efficient manufacturing
operations
 Provide safe, efficacious, and defect-free high quality drug
products
 Regulators
 Stand in for the consumer (patient) to ensure quality
 Exercise risk-commensurate regulatory oversight

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Continue at:  https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM456367.pdf

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