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.