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Training in pharmaceutical

Purpose of training

The knowledge required within a profession is redoubling increasingly rapidly; the "half-life" of
what was learnt during vocational training is ever shorter. If companies want to guarantee the
quality of their products, the "human factor" is a crucial variable. Staff must be adequately
prepared for the continuously increasing requirements in their professional environment. Only in
this way can the innovativeness of a company as a whole be guaranteed. To this end, training is a
crucial staff development measure. Training is intended to maintain the employees' skill features
and adapt them to changed conditions (further training). In principle, it is based on an existing
basic vocational training (e.g. pharmacologist, master pharmacist, engineer, pharmacist, etc.).

In accordance with Article 7 No. 4 of Directive 2003/94, training courses should in principle be
executed at the time when the employee first starts their job and then continuously thereafter.

Training should be planned in the form of approved training programs and must be periodically
assessed and recorded. Training of unskilled temporary staff must be given particular attention.
Here, training has the purpose of educating the temporary staff, i.e. of producing a still lacking
qualification.

Professional training (e.g. to become a specialist pharmacist) goes beyond internal training and
usually leads to a higher professional qualification.

2 Responsibility for training

Training is a management task. The management of the plant is not only responsible for
providing the required personnel and materials required for training and for releasing the
employees from work for training purposes, but it should also use corresponding social and
organisational measures to ensure that the employee can develop fully in accordance with his
qualification.

The strategic organisation of training includes the establishment of training guidelines in


corresponding process instructions, i.e. that the crucial factors for the quality of the training are
defined. This includes the selection of trainers, coordination of training activities and checking
the training system, e.g. through self-inspections. This is a typical task of the quality assurance
department, with the training manager being involved, if available.

The training manager develops the training plan, ensures proper execution of the training events
and their documentation and is involved in reviewing the level of success. The head of
production and the head of quality control are responsible for monitoring the qualification of
their staff. They stipulate the necessary technical content of the training, in collaboration with the
foremen, and release the employees for the training dates. The respective superiors review the
success of the training on-site and are involved in the practical education of their staff.
Figure 2.C-1 Concept of qualification-based training

3 Requirements profiles/learning objectives

Efficient training requires that the plant has compiled requirements profiles for the employees of
the individual areas. A requirements profile is a detailed description of the features that are
required in terms of the knowledge, capabilities and practical skills required to perform the
transferred tasks. Requirements profiles are usually derived from the employee's job description
or the description of their place of work. (chapter 2.A Place of work and job descriptions).

As both the plant requirements and the general scientific, technical and legal requirements
change, requirements profiles must be adapted as required.

An employee can only fulfil his tasks in accordance with GMP if he fulfils his requirements
profile.

In each case, there will be a gap of varying width between the theoretical requirements profile
and the employee's actual qualification. This gap must be closed through training. To this end,
the knowledge and capabilities that the employee still lacks must be determined, so that he can
fulfil his requirements profile. In this way, learning objectives are set, which must be achieved
during the training. Learning objectives are usually the acquisition of knowledge and practical
skills.

4 Training contents and target groups

The obligation to undergo training extends to all employees whose activity affects the product
quality or the safety of quality-related procedures. This also includes the persons who are not
actively involved in the manufacture and quality control of drugs, but who have an indirect
responsibility for the quality, such as, employees from the registration department, the
research & development department, the management (including the board of management) or
the engineering division.
As the employees must be employed based only on their knowledge and capabilities, the training
contents must be oriented to the individual requirements of the place of work. Workplace-related
training must be carried out regularly, at least once a year. In addition, training contents that are
to be applied throughout the plant should be communicated.

Figure 2.C-2 gives an overview of the relevant subjects.

Figure 2.C-2 Training subjects/content


Training subject Content (selection)
Company Legal form, company history, product range, business data, working time
introduction regulations, employee representation, canteen, introduction of the
departments' head
GMP GMP Guideline, Drug Law, pharma business regulation, Product Liability
principles/laws Law, finished pack regulation
Quality assurance Quality term, quality policy, structure of the QA manual, set-up and
concept workflow organisation, continuous improvement process (CIP)
Documentation SOP administration, document hierarchies, forms, document handling,
approval procedure, archiving, GMP-compliant recording
Sanitation Cleanliness zones, cleaning/disinfecting procedure,
air lock procedures, handling of open products, personal hygiene, reporting
procedure in case of illness
EDP Training in relevant software, authorised access/password assignment, data
backup/data security
Labelling Labelling of rooms and storage positions, labelling of the operating, cleaning
and maintenance status, handling of rejected material, status labelling on
containers
Changes Grading, execution and documentation, causes of deviations, reporting
and deviations procedure
Safety at work Protective clothing, noise/dust guard, heavy loads handling, monitor
workstations, health check-ups
5 Training planning

The need to train different employee groups in different subjects and in different frequencies,
requires accurate planning. Usually, plants have appointed training managers to perform this
task. The training manager knows the plant and the composition of the staff. He determines the
need for training, i.e. the learning objectives (cf. figure 2.C-1) in close collaboration with the
heads of the different areas (e.g. head of production and head of quality control) and then
executes rough planning (definition of the training subjects and frequencies) and then based on
this, compiles a detailed plan (definition of the training dates and rooms, selection of the training
groups and trainers) for the necessary training events. He monitors compliance with the dates
and ensures the smooth running of the events.

Planning and organisation of training events can also be undertaken using electronic training
databases. When deciding on the purchase and use of such programs, the internal function
requirements should be defined in advance.
These might include:

 Possibility of employee-based scheduling


 Subject-based display of the training events in the overview
 Organisation of training through the formation of training groups
 Target/actual comparison of the training requirements for each employee
 Possibility of separate recording and planning of additional training
 Possibility of compiling pertinent paper printouts

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