Risk assessment (German translation: Risikobewertung) involves analyzing and determining the probability and potential consequences of a risk in relation to the quality, safety or efficacy of a product, process or system. In the context of pharmaceutical manufacturing and Good Manufacturing Practice (GMP), risk assessment aims to identify, understand and keep factors that may affect drug quality and patient safety in check.

Phases of risk assessment:

• Identification of risks:
  
  • Identification and description of factors or situations that can lead to quality problems in products, processes or systems. This may involve the production process, raw materials, equipment, storage conditions, the human factor, etc.
• Risk analysis:
  
  • Assessment of the probability that a risk will occur and analysis of the possible consequences. In this phase, the possible causes of the risk are analyzed and the consequences for product quality, patient safety or process efficiency are assessed.
• Impact assessment:
  
  • Determining the severity of the consequences that may result from the risk occurring. For example, effects on patient health, the quality of pharmaceutical products or production losses can be determined.
• Risk ranking:
  
  • Classification of risks according to their severity and occurrence probability . This phase determines which risks require immediate intervention and which can be classified as acceptable or less significant.
• Development of risk management measures:
  
  • Determination of the measures required to reduce or eliminate risks. This may include corrective and preventive action, improvements to quality control procedures, the introduction of additional tests or a change in storage conditions.

Methods of risk assessment:

• FMEA (Failure Mode and Effects Analysis; German translation: Fehlermöglichkeits- und Einflussanalyse):
  
  • Method for estimating the errors likely to occur in a process and their possible effects on product quality and safety.
• HACCP (Hazard Analysis and Critical Control Points; German translation: Gefahrenanalyse und kritische Kontrollpunkte):
  
  • Used to determine critical process parameters and to analyze the risks associated with them.
• FTA (Fault Tree Analysis; German translation: Fehlerbaumanalyse):
  
  • Structured method used to analyze the causes of errors or problems and assess their likelihood and consequences.
• SWOT analysis (abbreviation for strengths, weaknesses, opportunities, and threats):
  
  • Method for assessing the internal and external risks associated with a process or project with a particular focus on the strengths, weaknesses, opportunities and risks.

Application of risk assessment in the pharmaceutical industry:

• Production processes: Risk assessment helps to identify critical production steps that could affect product quality (e.g. sterility, temperature control).
• Quality control is used to assess the risks associated with the testing and inspection of products at all stages of production in order to minimize the likelihood of errors or the manufacture of substandard drugs.
• Process changes: Before changes are made to production processes, a risk assessment is carried out to determine the potential impact of such changes on product quality.
• Supplier management: Risk assessments help determine the quality of raw materials and the work of suppliers to minimize the likelihood of using substandard materials.

The importance of risk assessment:

• Quality and safety: Risk assessments are used to identify and minimize risks that could compromise product quality or endanger patient health.
• Resource optimization: Focusing on the management of critical risks helps to utilize resources more efficiently and reduce production costs.
• Compliance with regulations: Regulatory authorities such as the FDA and EMA require risk assessments to be carried out as part of the pharmaceutical quality system to ensure the safety and efficacy of drugs.

In summary, risk assessment is a key element of the quality management system in pharmaceutical production and helps to prevent potential problems and ensure high quality and product safety.

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