Are you training your temporary employees on GMP practices?

Recently, a company received this observation ….

…. Employees are not given training in current good manufacturing practices.

Specifically, permanent and temporary employees who perform current Good Manufacturing Practices (cGMP) activities of manufacturing … including repackaged drug products, such as … have not received any GMP training. Additionally, your firm’s general manager/production manager, who performs cGMP activities and is reportedly the head of the quality unit, and who releases finished …  and jointly authorizes procedures, has not received any GMP training.

To read more about this observation as well as observations pertaining to manufacturing controls, laboratory controls, data integrity and medical devices, see our new issue 1040.

Stay in Compliance! Subscribe today!

Stay in Compliance!

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!

LEARN MORE
About GMP Trends

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

Available Reports
Stay in Compliance!

Sign up for free highlights and updates from GMP Trends


Report Categories
Recent Posts
Recent Comments
Archives
Categories
Meta

Become A Subscriber And Stay Ahead of the FDA

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!

SUBSCRIBE NOW