InstantGMP Compliance Seriesfor cGMP Dietary Supplements

Training Documentation

Electronic cGMP Manufacturing Execution System

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

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

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

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

Individual Training Form

Trainee Name:

Training Class Instructor DateSignature of Instructor orSupervisor

Electronic cGMP Manufacturing Execution System

Classroom Training Form

Training Session Topic:Instructor’s Name:

Trainee’s printed nameTrainee’s signature

(sign in pen only)Date

Electronic cGMP Manufacturing Execution System

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

InstantGMP™

Find more presentations on cGMP Compliance for Dietary

Supplements in the Resource Center at

www.instantgmp.com