1 Qualification requirements

Personnel with sufficient technical qualification must be available. Qualification means the theoretical knowledge, practical skills and professional and business experience of the employee. The legislator has left the definition of "sufficient" to the entrepreneur, who makes specific requirements in individual cases. These result from the type and scope of the activities carried out in the plant.

Qualification is not only expressed in the employee's technical knowledge. In addition to the requirements related to the place of work, management staff in particular are also expected to demonstrate social skills, as well as the ability to manage staff. Figure 2.B-1 gives an overview of the different qualification characteristics.

Personnel must be employed only "on the basis of their education and knowledge". In addition, the personnel are to be regularly instructed "on how to handle drugs and starting materials with due care". This includes instruction in sanitation, for example.

Chapter 2.1 of the EU GMP Guideline requires the manufacturer to have employees with the required qualification and practical experience. The training obligation, according to chapter 2.8, not only concerns the staff employed in manufacturing and quality control, but rather it concerns all employees whose activities could influence the product quality, such as maintenance and cleaning staff. Particular attention must be paid to the newly appointed staff (chapter 2.9), who are to be given theoretical and practical instruction in the principles of Good Manufacturing Practice (GMP) and trained according to the tasks assigned to them. Staff who work in special areas or who handle highly active, toxic, infectious or sensitising materials, are to be given special training (chapter. 2.10). In addition, the concept of quality assurance and all measures that can improve its understanding and application, must be discussed in detail.

§ 211.25 of the USA's Code of Federal Regulations (CFR) also requires the persons responsible for the training to have the required level of qualification, and § 211.34 requires the same of the consultants.

2 Health requirements

In order to preserve the staff's health status, superiors and the board of management must set up and monitor a health program throughout the plant. The procedure for medical monitoring of staff should be set out in writing in compliance with the criteria specified in figure 2.B-2.

It must be ensured that all persons involved in the production of drugs are subject to a medical examination before first taking up their activity (cf. figure 2.B-3) and later, to a repeat examination, if required (cf. figure 2.B-4). The medical examination has two functions:

It is intended to protect the staff from the effects of the product and thus represents an important measure in medical occupational health and safety. The respective employer's liability insurance association guidelines provide for special examinations in defined frequencies for certain substances (e.g. carcinogenic, radioactive or infectious).

It is also intended to protect the product from the effects of the staff. This concerns, in particular, staff who come into contact with the open product or with product contact surfaces (facilities, equipment). The aim is to prevent microbiological contamination of the drug through infectious staff.

The employer must provide the employees with adequate and appropriate instruction on occupational health and safety protection during their working hours. This instruction should include directions and explanations which are explicitly aimed at the place of work or task area of the employees. Instruction must take place before an employee begins his activity, upon starting the new job, if his task area changes, if new materials are introduced or if a new technology is introduced. It must be adapted to the development of risk and repeated regularly, if necessary (cf. § 12 Labour Protection Law).

The employer must enable the employee, at his request, to have a regular medical examination at work depending on the risks for his occupational health and safety unless damage to health is not likely, based on the assessment of the work conditions and the protection measures taken (§ 11 Labour Protection Law).

The examinations should be performed by an experienced occupational medic (company doctor or external contract doctor).

In accordance with § 3 of the Labour Protection Law, the employer is obligated to meet the necessary occupational health and safety measures, taking into account the circumstances which influence the occupational health and safety of employees. The employer must check the effectiveness of the measures and, if necessary, adapt them to changing circumstances. The employer must aim to achieve an improvement in health and safety protection for employees.

The employer must not transfer costs for measures in accordance with the Labour Protection Law to the employee.

The employer must determine which occupational health and safety measures are necessary based on an assessment of the risk associated with the employee's work. The employer must perform the assessment according to the type of activity. In the case of similar working conditions, the assessment of one place of work or one activity is sufficient. In particular, a risk can occur through the design and set-up of the workstations and place of work, through physical, chemical and biological effects, through the design, selection and use of work tools, in particular of work substances, machines, equipment and facilities as well as handling them, through the design of work and production procedures, operational cycles and working time and their interaction as well as through insufficient qualification and instruction of the employees.

When transferring tasks to employees, the employer must take into account, depending on the type of activity, if the employees are able to comply with the provisions and measures for occupational health and safety.

Occupational medical check-ups are an important source of awareness of operational health protection, but must under no circumstances be judged as the only source of information. Findings from physical examinations might fail to attract attention in the event of numerous exposures/expositions. In addition, the amount of information obtained from the doctor/patient meeting can be low if the employee is defensive due to various feasible motives. Therefore, it cannot generally be assumed that the company doctor will recognise the current, individual stress situation based on findings and discussions from occupational medical check-ups. It can in no way be concluded from findings and discussions that are not particularly striking, that the employee is with certainty healthy from an occupational medicine perspective, or is not subject to any risk at the place of work.

Guaranteeing effective health protection of the staff is beyond the scope of check-ups alone. It requires timely and comprehensive cooperation of the company doctor even in the planning and design phases of the plant. The importance of occupational medicine advice in advance of planning and investment processes is extraordinarily high and generally acknowledged. The company doctor can be involved in the determination and assessment of risks at the place of work. He can suggest protective and design measures. He can be involved in sanitation training courses and in the promotion of health within the plant. He can cooperate in the improvement of occupational health and safety within the operational organisation.