What are the three most important reasons for GMP deviations? A lack of GMP training, a lack of GMP training and a lack of
GMP training! The root cause for GMP deviations most frequently listed in inspection reports is the personnel involved in
API manufacture and quality assurance.1 GMP training for manufacturing personnel is essential, as defined in Chapter 2 Paragraph 2.9 of the EU GMP Guide and in
211.25 of the FDA cGMP Guide; however, GMP control is not always as good as it should be — as demonstrated by the increasing
number of warning letters, import stops and other provisions by regulatory authorities in past years.
Well-qualified employees are an essential part of GMP, and training concepts and the compliance status of personnel are always
within the scope of inspections. As such, requirements for qualifications, training and development of all employees involved
in GxP relevant operations must be met to ensure that employees can aptly perform their assigned tasks according to their
position. The best way to accomplish this is through training programmes tailored to each employee's job. This should not
just end with an induction programme, but continue with annual training plans and periodic retraining to ensure that an employee's
knowledge and behaviour is maintained at the required level.
Training should be planned, scheduled, conducted and documented using a very systematic approach, particularly in large companies.
In 2006, a publication by Schaffer/Schmidt described how a pharmaceutical company established key performance indicators (KPIs)
to calculate the ratio between the total number of trainings planned/needed, and the total trainings conducted, which helped
management to assess and assign the necessary resources.2 The overall conclusion of this publication was that a companywide training management system is needed to manage the training
needs in a pharmaceutical company. The administration of resources, as well as the involvement of the management, is a new
requirement defined in ICH Q10 Pharmaceutical Quality Systems.
Planning isn't easy
To plan and monitor GMP training in a pharmaceutical company, a lot of operational information is required. In the past, companies
often kept an archive of training certificates or lists of participants signed by each individual, or used spreadsheets, but
this approach may not be appropriate for a facility with well over 100 employees. Instead, many large companies are now implementing
a software control system to monitor the GMP compliance status and training of their employees. Such a system is more than
just a piece of software: it is a general approach to managing the complete process of GMP training, starting with assigning
individual training needs to each employee, through to an efficient documentation procedure. The system enables management
to easily identify training needs, provides reports regarding the overall training status and also enables the complete tracking
of training conducted per employee, which is useful for regulatory requirements.
The following case study describes how a GMP training management system (Pharmschul; Concept Heidelberg, Germany) was introduced
at Hoffman La Roche in Basel (Switzerland) to achieve the complex task of managing the GMP training of employees. The software
linked with Roche's document management system (DMS) to provide up-to-date information about the status of relevant training