Risk management (German translation: Risikomanagement) is a systematic process used to assess, monitor, communicate and review the risks associated with the quality of pharmaceutical products. This approach is intended to help identify potential quality risks at every step of the drug’s manufacturing cycle — from development to market authorization of the finished product — and reduce these risks to an acceptable level.

The most important components of risk management:

• Identification of risks:
  
  • Identification of factors that could jeopardize product quality. These can be different risks that can be related to the manufacture, packaging, storage (German translation: Lagerung) or transportation of drugs.
• Risk assessment:
  
  • Analysis of the probability of occurrence and the possible consequences of the identified risks. During assessment, the risks are ranked according to their importance for product quality and patient safety.
• Risk control:
  
  • Definition and implementation of measures to eliminate or minimize risks. Risk control can include changes in the manufacturing process, additional tests or increased monitoring of key parameters.
• Risk communication:
  
  • Informing all parties involved (employees, managers, regulatory authorities) about risks identified and the measures taken to minimize them. This contributes to a better understanding on all sides and ensures the necessary quality control at all levels.
• Review and monitoring of risks:
  
  • Continuously monitoring and reviewing the effectiveness of the measures implemented as part of risk management. This process is necessary in order to adapt and improve quality control (German: Qualitätskontrolle) before it is too late based on new data or changes in production.

Risk management methods:

• Failure Mode and Effects Analysis (FMEA; German translation: Fehlermöglichkeits- und Einflussanalyse) is designed to identify and evaluate potential errors in the production process and assess their impact on product quality.
• Hazard Analysis and Critical Control Points (HACCP; German translation: Gefahrenanalyse und kritische Kontrollpunkte) is used to identify and control critical process parameters that could affect product safety and quality.
• Fault Tree Analysis (FTA; German translation: Fehlerbaumanalyse) is a deductive method for determining the causes of potential system failures and for developing corrective measures.

Application of risk management:

• Development and introduction of new products: Risk assessment and management in the product development phase can prevent potential problems during the transition to large-scale production.
• Production processes: The risk management system enables the identification and monitoring of critical production parameters, such as storage conditions for raw materials or the condition of systems.
• Change control: Risk management is necessary in order to be able to analyze the consequences of changes to the production process, equipment or raw materials.
• Post-market surveillance: Once a product is on the market, a risk assessment is carried out in order to optimize quality control measures based on customer feedback or post-market research data.

The importance of risk management:

• Ensuring patient safety: Risk management helps to minimize the likelihood of manufacturing substandard products that could pose a risk to patient health.
• Compliance with regulations: Regulatory authorities require the introduction of risk management systems to ensure product quality and consumer protection.
• Resource optimization: Risk management helps to focus effort and resources on the critical aspects of manufacture, reduce costs and improve process efficiency.
• Improvement of product quality: Continuous monitoring and risk management help to maintain and improve the quality of drugs throughout their life cycle.

Risk management therefore plays a key role in the GMP system and is an important instrument for maintaining a high level of drug safety and efficacy (translation into German: Wirksamkeit).

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