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Risk Assessment

  • Risk Assessment

    • Overview
    Austar adopts the approach and concept of risk assessment for engineering projects and processes in our validation and consultancy service projects according to the requirements on quality risk management in regulations and guidelines such as ICH Q9 Quality Risk Management, EU Good Manufacturing Practice Annex 20-Quality Risk Management, CFDA Good Manufacturing Practice (2010 Revision), ISPE Baseline Guide Volume 5: Commissioning and Qualification, ISPE Baseline Guide Volume 7: Risk-Based Manufacture of Pharmaceutical Products, etc.
    Engineering risk assessment includes system impact assessment and component criticality assessment.
    System impact assessment will be performed the VMP is prepared. This assessment is the basis of the validation matrix and it summarizes the commissioning and qualification activities. All systems will be divided into three categories, direct impact systems, indirect impact systems and no impact systems, according to the assessment results. For the direct impact systems, commissioning and qualification will be performed. If necessary, computerized system validation shall also be performed. But for the indirect impact systems and the no impact systems, only commissioning is required.
    Component criticality assessment will be performed for each direct impact system to identify which components of the system are critical components, what risks are associated with the critical component, and how the risks shall be controlled.
    The purpose of the engineering risk assessment is to assist customers in determining the extent and the scope of qualification and validation activity to be performed.
    Process risk assessment includes production process risk assessment and cleaning process risk assessment.
    Production Process Risk Assessment: quality risk management approaches will be used by Austar to assess the production process, and finally determine the critical steps, the critical in-process controls, the critical process parameter and the critical quality attributes. It provides a basis for the qualification of the critical equipment, the validation of critical steps, the determination of the critical materials (raw materials and intermediates) and their specifications, the determination of in-process control points, and the equipment preventative maintenance plan to be used during commercialized production. And the product, the process and the systems are characterized.
    Cleaning Process Risk Assessment: Austar will group all the products manufactured in a facility, the equipment used and the process steps during cleaning validation process. And risk assessment will be performed for each group of products based on the relevant parameters and analysis methods to determine the final target product. Risk assessment will be performed for the product related equipment and the direct contact components to determine the sampling points of each piece of equipment. Cleaning process risk assessment can effectively prevent cross contamination and it also provides guidance to the the cleaning process.
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