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
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 documentation.