Parenteral Visual Inspection Compliance Regulations & More

Title: Current Good Manufacturing Practice (CGMP) Regulations

Source: U.S. Food & Drug Administration

Summary: The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

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Title: FDA Regulation of Medical Devices

Source: Congressional Research Service

Summary: This report is intended to provide a broad overview of FDA medical device regulation, and as such, it may not describe every applicable device requirement.

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Title: Medical Device Reporting (MDR): How to Report Medical Device Problems

Source: U.S. Food & Drug Administration

Summary: Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. This report covers reporting programs and requirements.

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