GMP Employee Training

 

 

Successful GMP Employee Training ensures that all employees receive appropriate, relevant, and documented training to perform their assigned duties safely and in accordance with applicable policies/regulations. It will look like this.

It is a GMP/GLP requirement that all employees receive training appropriate to their role. FDA-regulated industries must develop a GMP training for Employees policy and procedure for their employees that outlines the training approach, scope, responsibilities, and overall training system. There should be a clear process for identifying training needs and delivering, evaluating, recording and archiving training as required by local regulators.

 

Types of GMP Training for Employees

GMP regulated companies carefully decide what type of training is practical and beneficial for their employees. Below is a list of common GMP training courses offered at most GMP sites.

• Induction Training

• Skills Training

• Good Manufacturing Practice (GMP) Training

• Good Laboratory Practice (GLP) Training

• Quarantine Requirements Training

• Cloakroom Certification Training

• Occupational Health and Safety Training

• External Certification Training

• Work Permit System

• Personal Protective Equipment (PPE)

• Biosecurity

• Work System Permit

• Auditor Training

• Hazard/Incident Reporting and Investigation

From the above, new employee training, skills training, and occupational health and safety training , provided to all employees, contractors (including cleaning staff) and temporary staff.

GMP/GLP and PSA training is provided to all employees and contractors working in a GMP environment performing all activities, including manufacturing, packaging, labeling, distribution, quality assurance, quality control, development, validation, engineering, and IT personnel. Applies to contractors and temporary employees. Product quality may be affected.

Gown Qualification Training is in addition to the above training program for all employees working in cleanroom processing areas.

Quarantine and Biosecurity Training applies to employees working in organic processing facilities. Work permit training is required for engineers and project staff.