GMP Training

A well-documented and thorough GMP training program is a basic expectation of FDA inspectors of any company involved in the manufacture of therapeutic products and medical devices. Manufacturing organizations are expected to have standard operating procedures (SOPs) defining these programs. Current Good Manufacturing Practices require that training be an ongoing process.

Training Program Development

Our experts can assist you with developing and structuring an effective GMP training program to address the key expectations of the FDA and other international regulatory agencies (see below). We can also audit your current training program for compliance, completeness and effectiveness.

Scope of the Program
Training SOP's must clearly define the personnel or sites are covered by the training procedure. For example, the procedure might have a corporate-wide scope, or it might affect only one site or business unit.

Definition of Responsibilities
The Training SOP's must indicate which organization is responsible for providing oversight of training efforts, design and delivery of training events as well as auditing the program to document its effectiveness. Often, the delivery of training responsibility is split among units. For example, GMP training is frequently part of the quality assurance (QA) unit while SOP and skill training are the responsibility of the individual operations area.

Define Training Frequency
GMPs require that training be ongoing. Formal GMP training or reinforcement of previous training are expected to be delivered at least annually. Training on specific GMP-related skills should be considered here as well.

Quality Unit Responsibility
The quality control (QC) or "quality assurance" (QA) unit should be responsible to approve various elements of the training program. QA review and approval of GMP related training courses are particularly important. QA approval indicates that the courses have been evaluated for completeness and accuracy, covering topics and using examples that are relevant and meaningful to the company specific operation. The quality unit also should review and approve GMP-training curricula for job functions or positions. Periodically, the QA unit should audit the training records for each person to ensure that the prescribed training is taking place.

Training Plans and Curriculum Requirements
A training plan or curriculum required for a position must define the instructions that person needs and the recommended sequence of training for their job function. The list of procedures, protocols, and methods used is also part of a person's training plan. Training plans should be developed for everyone in a GMP organization, including all levels of management. The quality unit should review and approve the training plan for each job function.

Instructor Qualification
GMPs require that instructors be qualified as described in your training SOP where you have a chance to define what that means. Your definition of Instructor Qualification must indicate the minimum requirements, such as successful completion of basic and advanced GMP training along with specific training in communication skills such as successful completion of a presentation skills workshop.

Training Documentation
For department-led sessions the minimum information is a sign-in sheet with each person's name, signature, name and number of the course, date of the session, and the instructor's name and signature. The participant's signature attests to his or her attending the complete session. The instructor's signature attests that the program was given and that the people listed actually attended.

Documenting Training Effectiveness
The GMP training process itself should be evaluated on a scheduled basis to ensure it is consistent with agency expectations and updated as appropriate to include recently published agency guidelines. Not only are you expected to train all personnel involved in GMP manufacture activities, it is expected you will have methods in place to document the effectiveness of the GMP training program itself.