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FDA Inspection Guidance

The FDA requires even foreign manufacturers to follow "good manufacturing practices" (GMP) in order to be allowed to ship bulk products into the US.  These GMPs are all written up and formalized in other documents which the FDA doesn't require manufacturers to follow, but they also won't approve a drug or allow bulk products and finished drugs to be imported until a manufacturer demonstrates that they are following them.  The FDA doesn't assay batches or finished drug products directly, but expects the manufacturers to test their own raw materials and finished products, report on themselves, and take corrective actions whenever something isn't up to snuff.

The foreign manufacturers "certify" the bulk products they send into the US, and then the manufacturers here, who process them into drug form, test their products for purity, concentrations, etc. , at one or more logical points in their manufacturing process.

"FDA approval" means they review and evaluate the safety and efficacy data companies provide to them about new products, and then OK the company's manufacturing processes and procedures, recordkeeping practices, etc.

I found this FDA inspection guidance document to be pretty interesting and helpful to start understanding what the FDA requires/expects with regard to bulk pharmaceutical chemicals.  It is written for use by FDA inspectors, but had references to the relevant regulations with which manufacturers must comply.
http://www.regsource.com/Biologics/Compliance/compliance.html

Val Barnes

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