As a QA Manager for a plasmid manufacturer, I am always looking for innovative ways to maintain a focus on cGMP and help employees understand its importance. cGMP training accomplishes this, but it only occurs once or twice a year in most organizations. If you do not have a dedicated training department, it most likely only occurs once a year.

I devised a simple way to provide cGMP information to employees on a more frequent basis. It is called the GMP Newsletter. It is published once a month by QC and may include information on GMP regulations or general GMP related topics. The newsletter requires an employee signature to document that the employee has read and understood the newsletter, and it is filed in their training binder.

The newsletters we have issued have covered a vast amount of subjects. One of the most interesting was a series of articles on the history of cGMP regulations. It included a timetable for the implementation of the statutes and highlighted significant events that led to certain ones (i.e. Upton Sinclair’s book The Jungle, the Tylenol scare, etc.).

Other content included audit preparation, good documentation practices, investigating human error, and even one consisted of a crossword puzzle with terms frequently used in a Quality System. Topics can be almost anything.

The idea is to keep a continuous focus on Quality and GMP by providing information on a more periodic basis, and a monthly newsletter has proven to be an effective way of doing that!

– Dorothy P.