Risk based approach

A quality risk management approach should be applied throughout the lifecycle of a medicinal product. As part of a quality risk management system, decisions on the scope and extent of qualification and validation should be based on a justified and documented risk assessment of the facilities, equipment, utilities and processes. Risk assessment should be performed for:

• risks of cross-contamination and mix up
• products
• production lines
• premises, equipment and utilities

The operational and performance qualification provides information on deviations might occur. Within the qualification, we assess how these deviations can affect the utility performance. Based on the risk analysis, we rank the deviations to critical, major, minor and give recommendations on required corrective actions. These recommendations are the basis for developing a deviation SOP.

We recommend that risk assessments should be repeated as knowledge and understanding are expanded due to any changes during the design phase or during operation. The initial risk assessment, which is carried out together with specialists of our company will be a good basis for the next risk assessment.

The frequency of re-qualification (re-qualification) will also be determined using a risk analysis.