by John Neeb

Created on: December 30, 2009

Can Generic Drugs Be Trusted?

When faced with the decision to either purchase a brand name drug or save some money and buy the generic version, a consumer might be worried about the safety and efficacy of the low cost alternative.  Due to stringent industry regulation, though, there needn't be any greater concern about taking a generic drug than there is for a brand name one.

All drug products, whether name brand or generic, are regulated by Food and Drug Administration (FDA).  FDA's primary concern is with the safety of products intended for human consumption.  This federal agency wields great power over pharmaceutical companies, including the ability to invoke a court injunction to force a company to stop manufacturing and distributing product if there is reasonable justification for doing so.

Companies which manufacture generic drugs are just as responsible to FDA as are the ones which produce name brand drugs.  In the eyes of this particular federal agency, all products are viewed as equal.  Generic drugs receive the exact same level of scrutiny.

Given that pharmaceutical companies do not want to draw the ire of FDA, the industry does a reasonable job of self-regulating itself.  Obviously, the industry does not do a perfect job, but there are several measures used industry-wide to help ensure the safety of manufactured products.  Companies which manufacture generic drugs follow the same steps and utilize the same systems.

One measure to ensure safe products is a system of extensive documentation.  From the moment raw materials are received by a pharmaceutical company, all the way through the final stages of processing, every step taken is documented and usually checked by a second individual.  So if one particular product requires the addition of twelve raw materials, the person adding each material will sign a batch record and a second operator will verify the ingredient and amount added, and then also sign.  This system creates a tremendous amount of traceability and accountability.

Records used in the manufacture of both generic and brand name drugs are retained for years, usually beyond the expiration date of the actual product.  At any time, FDA may come through to audit a company and request batch records for review.

In addition to the checks and double checks in place, pharmaceutical companies, even those which manufacture generic drugs, have extensive quality systems in place.  Products

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