Non-compliance = eventual problems

· Superpotency/subpotency
· Contamination
· Misbranding
· Bioavailability
· Safety and efficacy

  

III. CGMP Legal Principles

          Non-compliance
 
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If a firm does not comply with CGMP when producing a product, problems will eventually occur with undesirable outcomes. Listed above are some of the problems we have encountered as a result of inadequate manufacturing conditions and practices.

Let's take cross contamination as an example. Most manufacturing sites produce two or more drug products, which automatically affords the possibility of cross-contamination. If aspirin is produced at a plant where CGMPs are not followed, the likelihood of aspirin carryover into another product is very real--perhaps into a product that the label says is a non-aspirin drug. Some people are very strongly sensitive to aspirin and could experience serious adverse health effects from taking such a product. In this situation, when contamination occurs, you can also have efficacy problems as well.


References:

1. Please visit the web site of the FDA Enforcement Report. The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities. You can search the reports by entering key word(s), for example, "cross contamination".

2. FDA Consumer is the official magazine of the Food and Drug Administration. It reports on current FDA activities to ensure that the products the agency regulates are fit to use. You can also search the articles by entering key word(s), for example, "misbranding".

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