Today, identification and adequate handling of risks is a major quality management duty, and its weight grows with each guideline revision. Yet in reality, risk management often receives little or insufficient attention at best. One reason is that its potential for enhancing quality management of systems, processes and process environment is not always easy to recognize. This becomes even more concerning considering the negative consequences which can arise from a disregard of risks at hand.

Thus an early detection of potential risks, their exact assessment, and a consistent pursuit of adequate preventive measures are rightly called for. This requires a risk management and control system which is effective yet still manageable in the daily GMP grind.

Moreover, the positive impact of sound individual risk analyses must not be underestimated, as they oftentimes permit a reduction of costs.

Our experienced consultants will be happy to support You in establishing an efficient risk management system, which satisfies GMP demands. Naturally we will also help You with individual risk analyses.

Our services comprise:

  • Establishment of comprehensive risk management systems including training of employees
  • Risk analysis moderation (e.g. for complex FMEAs)

Performance of risk analyses:

  • Assessment of manufacturing processes regarding critical quality attributes (CQAs) and process parameters (CPPs) for process validation activities
  • Identification of critical lead compounds (Worst Case) for cleaning validation
  • Risk determination when planning or reconstructing buildings and facilities
  • Risk assessment for deviations, changes and complaints
  • Risk based definition of necessities of supplier audits
  • Risk based definition of the extend of environmental monitoring and validation activities (clean rooms, manufacturing areas, storage facilities, transport)
  • Supplier risk qualification in the framework of supply chain management
  • Determination of design citeria for GMP media systems (e.g. water and air) and clean rooms
  • Definition of necessity, extend and depth of supplier qualification
  • Definition of the extend of equipment and instrument calibration, including acceptance criteria and calibration schedule
  • Determination of extend necessary for validation of computerized systems