Monika Brunn

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.

  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.

  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 

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 documentation. 

For a company the size of Roche, which has many different objectives for employees, such as global guidance or company-specific GMP standards, it is necessary to merge employees to groups either in organisational or functional areas. From there, appropriate training can easily be set up. On the other hand, however, there are also local requirements that are pre-defined for a specific job. Today, Roche creates groups and assigns profiles to them using Pharmschul

to develop suitable trainings. Different roles and functionalbased assignments can be combined to receive a complete set up for each employee.  

Operating a packaging line, for example, presumes the employee has very special and detailed knowledge of technical documents tailored to one unit. Using the control system software, the company groups documents to document profiles according to different needs, or attributes certain documents to a specific job profile. Once a new document version is available in the DMS, a new draft training record is automatically created by Pharmaschul, and the training coordinator can then create the new record for the assigned group immediately. Different document profiles can be assigned directly to groups or persons, but the system can also connect document profiles to job profiles, which simplifies administration. It is also possible to group global guidance documents to dedicated global profiles, which can be applied to an entire organisational unit. 

As Roche operates globally, employees will sometimes assume new responsibilities and training for such employees must be adapted accordingly. In this case, the training manager can easily assign the new, appropriate functional group to the person. The employee's 'old' specific job profile can then be attributed to another staff member and the required training is immediately visible. An additional interface between Pharmaschul and Roche's human resources database also ensures that when an employee leaves the organisation, he/she is automatically removed from all profiles and all planned training sessions to avoid confusion. 

We also use the profiles to prepare annual staff training plans, which are created and assigned to the relevant groups. A formal report template is also available to print an annual training plan for a single employee, manually signed by line manager and employee.  

Making sure employees know about new or updated SOPs 

Standard Operating Procedures (SOPs) are necessary to introduce GMP standards into company-wide quality systems, and all employees need to be informed when a new or updated SOP is published. While this is easy in a small company, it is a rather more complicated task in a global entity like Roche. Because of this, we also introduced an additional web-based front-end for Pharmschul, called PharmschulWEB, which provides a validated solution for the completion of self-studies on procedures/SOPs, with electronic signatures.  

When a new document in the DMS has been issued for training, the training manager attaches it to the relevant group, and an integrated email function then informs employees about the training. The email will contain a link to a web interface and the assigned document, which the employee can open, read and countersign with an electronic signature. In their personal screen, users can also obtain detailed information about their training status, including performed, planned and open trainings. We also use the web interface for refresher information about GxP and regulatory requirements or issuedriven training, such as retraining in response to deviation, defects or complaints.  

A reporting system provides oversight of all training required and performed. One of the reports most frequently needed by management is the evaluation of training of one specific document; for example, to verify if all persons who need to be trained in a certain SOP have already been trained in the current version of the SOP. This functionality may seem basic, but it is extremely helpful in providing an overview about the training status of specific jobs, mapped with job profiles. Roche established such a matrix with an integrated Pharmschul report, which is a graphical list where compliance and (hopefully no) gaps are visible at a glance. The actual training status of employees is automatically reported periodically to management, providing line managers with transparent information of their responsibility in ensuring personnel are trained accordingly. We have found that this information has led to a high status of compliance. 

A KPI report for the higher management is also regularly used. Our higher level management forces the monitoring of KPIs, with all employees having a dedicated amount of training to be performed per defined period. The ratio between the total number of trainings, and the planned/required training has to be reported regularly, and helps to justify adequate resources for the technical and GxP training of staff. 

Managing GMP training is a complex task, particularly in large companies where Excel spreadsheets and certificate archives are not feasible. Because of this, Roche implemented a professional GMP training system that helps to identify and evaluate training needs, and assign these to each individual in the company. Only with a complete system in place can large companies ensure that every employee receives the necessary information and training. 

1. ECA Foundation, FDA Warning Letter Report (2010). 

Articles

A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.