Training and documentation of training is an essential element of Good Manufacturing Practices. The FDA expects all personnel who are in manufacturing and quality operations to be trained for their specific duties and tasks. The training may include general GMP requirements training, educational development, job specific skills enhancement, leadership development or SOP specific training. In any event, all training must be documented. The documentation usually follows a standard operating procedure.
Training Documentation SOP:
The purpose of a training documentation SOP is to describe the type of records that will be stored as evidence of personnel training and staff development. The scope could apply to all personnel in a firm or be limited to those working in GMP regulated operations like manufacturing and quality. Some position in the company needs to be made responsible to assure that the procedure is followed, it remains consistent with current practices and is reviewed and updated as necessary.
There are some general requirements of any training documentation procedure. All personnel performing an assigned GMP function in the facility will have a training file. Each training file will contain personnel curriculum vitae or resume. CVs or resumes will be updated periodically. Each training file will contain training forms and other documentation to provide evidence of personnel qualifications for performing assigned functions and for continuing education documentation.
The SOP itself can be fairly brief. If can have a general set of steps that are followed for each employee. An example process is:
- A training file created when new employee arrives.
- The file initially includes following documentation:
- CV or resume
- Job related training documentation
- Career development training
- As training is completed, training forms and other documentation is added to file.
An example of an individual training form is shown. This form might be used for one-on-one training for SOP specific training.
An example of a Classroom Training Form is shown. This form would be used each time a group training is conducted. The completed form would be copied so each trainee can have a separate form to put in their individual training file.
Training is one of the fundamental activities that any employee must undergo especially when they are new to an organization. While there are lots of opportunities for on-the-job training that occur, some formal training is necessary to assure the new employee is exposed to the values and processes of the organization. That will help them become acclimated to their new job and increase the rate at which they can become productive. Ongoing training assures they will stay productive and enhance their skills. The FDA insists on training documentation because that is the only way they can determine if facility personnel know how to be compliant with GMP regulations and with company processes.