In any manufacturing operation involving human manipulation there are hazards which may be created by preoccupation, mental lapse, carelessness and the like.  Therefore, all on-the-job and CGMP training should be revisited at frequent intervals and needs to be conducted by qualified individuals.

A firm is expected to establish detailed written procedures (training program) outlining the specific areas of the firm’s operation to be covered.  On-the-job training is acceptable, as long as the training is conducted by a qualified individual on a frequent basis.

Any employee involved in the manufacturing, filling, processing, handling, holding, or shipping of a medical drug is required to be trained both on-the-job and in the current good manufacturing practices.  This would include all delivery and/or truck drivers who deliver medical drug products.

The lack of CGMP training is one of the most overlooked areas observed at most medical gas firms.  CGMP training should be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements that are applicable to their function.  Conducting CGMP training once a year is not recommended, but instead should be presented in smaller more manageable portions, presented throughout the year with documentation* of the type, time, and attendance of each session.

Applied offers CGMP training books and online classes to help get you compliant for the year. Click here to find out what training you need.

*All training must be documented.