Good Manufacturing Practices emphasize the need for training personnel on GMP principles and the specific requirements of their job. This presentation describes the requirements of a training program and offers some example training documentation forms.

1. InstantGMP Compliance Series
for cGMP Dietary Supplements
Training Documentation

2. GMP Training
• FDA expects GMP personnel to be trained for
their specific duties and tasks
• Training includes:
– General GMP requirements training
– Educational development
– Job specific skills enhancement
– Leadership development
– SOP specific training
• All training must be documented
Electronic cGMP Manufacturing Execution System

3. Training Documentation SOP
• Purpose – describe how training will be
documented and evidence of training stored
• Scope – applies to all personnel in GMP
regulated operations
• Responsibilities – defines who is responsible for:
– Procedure is followed
– Procedure remains consistent with current practices
– Procedure is reviewed and updated as necessary
Electronic cGMP Manufacturing Execution System

4. General Requirements
• All personnel performing GMP function will have
a training file.
• Each training file will contain personnel
curriculum vitae or resume
• CVs or resumes will be updated periodically
• File will contain training forms and other
evidence of personnel qualifications for
performing assigned functions
Electronic cGMP Manufacturing Execution System

5. Typical Training Process
1. Training file created when new employee
arrives
2. Initially includes following documentation:
• CV or resume
• Job related training documentation
• Career development training
3. As training is completed, training forms and
other documentation is added to file
Electronic cGMP Manufacturing Execution System

6. Individual Training Form
Trainee Name:
Signature of
Training Class Instructor Date Instructor or
Supervisor
Electronic cGMP Manufacturing Execution System

7. Classroom Training Form
Training Session Topic:
Instructor’s Name:
Trainee’s signature
Trainee’s printed name Date
(sign in pen only)
Electronic cGMP Manufacturing Execution System

8. Importance of Training
• On-the-job training is good, but not a complete solution
for training
• Formal training exposes new employee to organizations
values and processes
• Increases rate at which they become productive
• Ongoing training enhances skills and increases
productivity
• FDA requires documentation to assure personnel know
how to be GMP compliant
Electronic cGMP Manufacturing Execution System

9. InstantGMP™
Find more presentations on cGMP
Compliance for Dietary
Supplements in the Resource
Center at
www.instantgmp.com