1. Purpose
To provide requirements for management and documentation of training and also to outline recommendations on how the requirements can be met.
2. Scope and Applicability
This Guideline is applicable to all sites, functions and departments undertaking work or providing support services required to meet Good Manufacturing Practice (GMP) and/or Good Distribution Practice (GDP) and/or International Organization for Standardization (ISO) standards. Personnel comprise both internal employees and external contract personnel conducting work in the facilities.
3. Definitions
3.1 Contract Personnel
Contract personnel provide a service or perform a task on behalf of a company and do so within the company facilities, but are not employed by the company itself.
4. Responsibilities
Management is responsible for defining and establishing robust training systems and allocating adequate resources and competency to ensure that the appropriate training is provided, undertaken, and that evidence of this training is properly recorded.
5. Guideline
5.1 Job Description
All employees must have an approved job description defining at least their MP/GDP accountabilities and responsibilities. Job descriptions can be individual or general, e.g. applicable for a group of persons. Job descriptions must be current and reviewed on a regular basis, for example yearly.
5.2 Training Procedures
There must be written procedures, defining accountabilities and responsibilities for establishing and maintaining systems for training. These procedures must define the requirements and scope of training. It is recommended that the training procedures define elements such as:
* General training plan / training program for individuals or general, e.g. applicable for a group of persons
* Training frequency
* Training assessment
* Training records
5.3 Personnel Requiring Training
5.3.1 General
All personnel must be aware of and be trained to the quality regulations, procedures, guidelines and company standards applicable to their area of responsibility. They must receive basic, job specific, continuing and refresher training relevant to their needs and appropriate to their duties.
An employee’s formal education, previous training and experience should, together with the requirements as defined in the job description/role descriptor, form the basis for defining the individual training program. All trainees should be supervised until they are assessed as competent to do tasks independently. Records to demonstrate successful completion should be available prior to individuals independently doing critical tasks.
5.3.2 Contract Personnel
The experience and training background of external personnel working within the company facilities and performing tasks that could impact on product quality, safety or efficacy must be adequate for the tasks performed and must be documented. Confirmation of their competence should be satisfied before they are permitted to work unsupervised. Training records should be accessible.
5.3.3 Visitors/Untrained Personnel
Visitors or untrained personnel must be closely supervised. Visitors or untrained personnel taken into restricted areas such as archives or production areas should be given sufficient information in advance on hygiene, safety, and protective clothing or other restrictions.
5.4 Skills of Trainer Involved in Developing or Delivering Training
Training must be provided by appropriately qualified and experienced personnel and/or by external experts or consultants.
The individuals involved in training should have sufficient specific knowledge for the topic. In addition, communication, presentation and organizational skills should be considered when selecting the trainer.
5.5 Types of Training Required
Training programs for individuals or groups, designed to fulfil the requirements of their job description, must be established. Training should encompass theoretical and practical aspects of the job including training in procedures.
The following types of training are generally used and should be considered the essential elements of a training program:
5.5.1 Basic Training
Basic training should cover the applicable essential areas of GMP, GDP and/orison in theory and practice in order to provide an understanding of how these regulations apply to the pharmaceutical industry and to the business area in which the trainee is employed.
5.5.2 Job Specific / Task Related Training
Job specific/task related training covers the essential GMP, GDP and/or ISO skills related to tasks performed within specific jobs in order to ensure individuals are able to demonstrate practical and competent application of these skills.
5.5.3 Continuing Training
The purpose of continuing training is to maintain and enhance current GMP, Gain/or ISO awareness, knowledge, know-how and best practice for the appropriate personnel, concerning new or changed regulations, regulatory guidance or current initiatives.
5.5.4 Refresher Training
Refresher training is repeated training to ensure that the required level of knowledge, awareness and competence is maintained. The need for refresher training should be assessed on an individual basis to a time scale defined by the site/function, e.g. defined period of time since last performing a task or tasks. It is recommended to provide refresher training on a regular basis, for example yearly.
In addition, certain incidents might warrant the need for refresher training, e.g.:
* A compliance weakness/breakdown, such as a quality incident, deviation, procedural failure
* An adverse trend is detected
* An extended absence
5.6 Identifying Needs for Training
The needs for training must be regularly evaluated. Areas to consider in such evaluation should include:
* New or revised global or local procedures (which should identify the scope of training required)
* Review of inspection outcomes
* Changes to facilities, processes, systems, etc.
* Changes within organization and/or teams
* Recurring problems
* Quality incidents or findings
The areas to be considered should be based on the responsibilities of a person or function.
5.7 Assessment and Measurement of Training Effectiveness
It should be determined which training events require an assessment, to measure the effectiveness of the training, and how this should be done. This assessment should verify the ability of the trainees to competently apply all tasks they are required to undertake. Examples of techniques that could be used are: written or verbal tests; observation of the employee in the execution of his or her job; feedback from internal or external contacts.
5.8 Training Records
Each employee must have an accurate and up to date training file that contains records of all relevant training events. The frequency of updating the training file must be defined in local procedures. The purpose of individual training records is to provide verification of participation in training event and should contain information on when and by whom the training was conducted.
5.9 Curriculum Vitae (CV)
Where deemed necessary, appropriate details of training, formal education and experience could be contained in one document, typically referred to as a Curriculum Vitae (CV). The employee should ensure this is kept up to date.