International Research Journal of Education and Technology

The aim of the present work is to identify and evaluate the risk factor involved in Qualification of PLC operated System and to provide risk mitigations. Risk assessment involved various tools and techniques  to identify, evaluation communication and control techniques  to minimize affect of risks  related to the safety, quality, reliability or durability of a product to be processed in PLC operated conta blender and to get maximum benefits & compliance of cGMP from PLC system.

Risk assessment approach in qualification of PLC Operated Cont blender includes operational parameters & others functions of equipment which may have impact on patient safety, product quality and data integrity. The scope of this document is to identify the Risk involved in qualification of PLC operated conta blender.

The advantages of risk assessment leads to providing assurance and documented evidence that equipment will perform as per predefined parameters and produce same results during every operation and developing suitable control systems in the PLC operation procedure of conta blender.

The goal of Risk assessment is to determine the criticality of the system to the process (with respect to product efficacy or patient safety.

Risk assessment based qualification approach provide assurance & acceptance criteria for the PLC Control system & its supporting automation that “Conta Blender (1200 Ltrs)” installed will perform as per quality & cGMP procedure in the processing environment. & control system

Risk is the combination of the probability of occurrence of harm & the severity of that harm.

    Keywords: Quality Risk Management, Risk- based approach, Patient safety, and Product quality