GMP Tips - Use Warning Letters to Gain Insights - Sept 7, 2006

Using FDA Warning Letters in your GMP training is an effective way to reinforce specific aspects of Good Manufacturing Practice. Recently, a Warning Letter was issued to a manufacturer of medical devices. This short (three-page) Warning Letter identifies three specific areas of concern:

1. Failure to establish and maintain quality requirements for suppliers and contractors.
2. Documentation of the monitoring and control methods during validation of processes.
3. Failure to analyze complaints.

Read the details of what FDA addressed and you will gain insights into what FDA looks for when conducting an inspection. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down to the entry labeled Command Medical Products Warning Letter.

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