Are Your Employees Properly Trained?

Do you have a well defined program to ensure your employees know what they are looking for during a visual inspection?

A company recently received this 483 observation: 

…..Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.

Specifically, employees performing your incoming quality visual inspection process associated with your glass components are not adequately trained.  Your employees do not utilize physical glass components, nor do you objectively measure this training process.  This incoming quality inspection is critical to the prevention of container/closure integrity defects which affect critical attributes such as sterility and potency.  The glass components are used as the primary container in all your sterile products, including but not limited to …..

For more observations pertaining to Manufacturing Controls for Sterile Manufacturers see Issue 1014 available today.  It features observations from Sterile Manufacturers on our rotating page 3 topic as well as Laboratory Controls and Medical Device Manufacturing Controls.

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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format. Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

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