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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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