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 gmp-experts 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 risk management support services:
- Qualification of facilities (clean rooms, storage areas, installations and equipment)
- Calibration (installations and equipment)
- Validation (manufacturing processes, cleaning, transportation, computerized systems)
- Supplier qualification and qualification of service providers
- Monitoring activities (clean rooms, storage areas and facilities)
- Quality assurance activities (processing of deviations, changes and complaints)
- Supply chain activities and auditing
- Planning of new or reconstruction of buildings and facilities
- Determination of design criteria for GMP media systems (e.g. water and air) and clean rooms