Standards of Maintenance and GMP

A key element of GMP is the importance of ensuring that equipment and control systems are maintained in optimum operating condition. Failure to do so could close a production line, or at the very least compromise the quality of the product.

This is an in-house training DVD which highlights the basic principles of Good Manufacturing Practice for maintenance personnel and instrument mechanics working in a pharmaceutical manufacturing environment.

Maintenance personnel, instrument mechanics and engineers spend a lot of time working in production areas and need to understand how GMP can influence the way in which they do their work.

The DVD is designed especially for induction training of new employees unfamiliar with the stringent requirements associated with the manufacture of healthcare products. It is also suitable as a refresher for experienced personnel.

On completion of this module, the trainee will understand:

• that the GMP disciplines incumbent on process operators apply equally to anyone entering or working in production areas.
• examples of good and bad practices.
• the potential risk of contamination and cross-contamination, working on plant or systems that come into direct contact with the product.
• the importance of hand written records and mandatory requirements for the recording of maintenance activities.
• the importance of following Standard Operating Procedures (SOPs).
• the meaning of validation, in terms of their own sphere of activities.
• the need for high standards of cleanliness and personal hygiene.
• the principles of correct gowning, according to the product and working environment, when entering production areas.