20.08.2014 |

LOGFILE No. 26/2014 - Principles of Human Resource Management

Principles of human resource management

An excerpt from the GMP MANUAL

by Dr. Michael Hiob

Employees are more than just production and cost factors. Their qualifications and commitment contribute substantially to the achievement or non-achievement of corporate objectives. This is why the human resources of a pharmaceutical company must be seen as part of the intangible assets of the business. They are a key element in the longterm strategy for sustained corporate stability and success.

Pharmaceutical companies need employees with proper qualifications who are in the right place at the right time if their highly differentiated manufacturing and test processes are to function properly. For this reason, the deployment of human resources (human capital) must be carefully planned and organised. This is a task for human resource management.

Good human resource management

  • is aware of the abilities, skills, qualifications, experience, motivation and flexibility of its employees and ensures that they are optimally deployed and receive training on an ongoing basis
  • concerns itself with the physical and mental health of the employees and is aware of positive and negative factors that can affect health
  • is involved in the recruitment of employees and when making decisions on the optimum deployment of human resources
  • advises senior management when establishing an organisational structure that clearly defines tasks and responsibilities.

Figure 1 contains an overview of the tasks of human resource management.


Fig. 1: Tasks of human resource management

Human resource management decides on the conditions under which personnel are deployed in a specialised pharmaceutical company. The HR department has to meet the needs of the company and represent the interests of the employees at the same time. Conflicts of interest cannot always be avoided because the objectives of the company (especially economic, environmental and strategic objectives) and the individual objectives of the employee have to be taken into account. The company can only be sure of its success if conflicts of interest are successfully resolved. Poor human resource management compromises employee commitment. Suggestions for improvement, the efficient use of working time and economic use of materials depend on staff motivation. Motivation is not just a question of a decent salary. The general conditions at the workplace alone (e.g. working atmosphere, flexible and family-friendly working times, quality of the canteen) are often why an employee decides to relate to the company.

Duties of senior management

The exercise of managerial responsibilities is essential if a QM system is to be effective. This especially applies to the GMP-regulated sector. Senior management1 decides on the design, implementation, control and continuing development of the QM system. It is responsible for ensuring that the enterprise is using state-of-the-art science and technology and is observing the rules of good manufacturing practice.

An important prerequisite for QM systems is a list of objectives that have been clearly defined by the company's senior management. These objectives are generally adopted in the form of crosscompany guidelines. The guidelines define the quality philosophy and strategic objectives for the entire company. The quality policy should contain a commitment to meet the legal requirements and improve the QM system continuously. The quality policy applies to all persons in the company, regardless of organisational hierarchy. It should be formulated and communicated to reflect this.

Additional sub-objectives at the operational level can be derived from the quality policy. This type of quality objective can be defined for products, organisational areas or procedures/processes. Defining operative objectives usually requires the definition of objectives for quality, costs and schedules. These can include general guidelines for the entire company as well as regulations to suit local conditions. The QM system is documented in the QM manual which is authorised by senior management. The main features of the QM manual include

  • the quality policy
  • the definition of the scope of the QM system
  • a description of the quality-relevant business processes, procedures and relationships
  • a description of the tasks and responsibilities within the organisational and operational structure.

To make quality objectives achievable, senior management must provide appropriate framework conditions. These include organisational specifications, adequate staffing and the necessary financial and material requirements.

Senior management must regularly check to what degree the defined objectives have been achieved (management review). Every pharmaceutical company has an extensive reporting system in place at operational level which communicates the results of process and product inspections. The conclusions reached from these evaluations should be presented to senior management so that it can convince itself that the QM system is functioning properly. In addition, senior management evaluates the typical key performance indicators of the QM system:

  • Management of deviations/complaints, changes, as well as corrective and preventive actions
  • Experience with contractual activities
  • Results from self-inspections and/or audits, risk evaluations and trend analyses
  • Results from evaluations carried out by third parties, e.g. authorities or customers

The management review should include all phases of the product and/or process life cycle. According to the ICH Q10 document "Pharmaceutical Quality System" (see Chapter E.10), the respective phases can be assigned the following contents:

  • Pharmaceutical development: evaluation of the appropriateness of the product and process design in laboratory scale
  • Technology transfer: ensure that the developed product can be manufactured in industrial scale
  • Commercial manufacturing: evaluation of the appropriateness of the product and process design in industrial scale
  • Product discontinuation: evaluation of product stability and complaints


Dr. Michael Hiob
Ministry for Health of Land Schleswig-Holstein, Germany

This article is an excerpt from the GMP MANUAL.

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