Module 16 2022

Where is Risk Mgmt also important ?

ISO 11608:2022 Definition a) Accurately deliver the medicinal product via the correct route (e.g. clinical function) b) failure to meet the specification result in unacceptable harm to the patient Essential Performance Requirement (EPR) Definition (e.g. FDA) **Functions and components that have potential to harm the patient or affect the mechanics of the clinical performance of the product IEC 60601-1 (electromechanical devices only) Performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk

Risk level defines control in Development - Design Verification - Shipping Verification - Process Validation - ....

Risk level defines control in Commercial Manufacturing - IPC - Sample Sizes - Batch Release - Incoming control - ....

** definition of EPR requirements subject to change in lieu of FDA guideline (in clearance at FDA)

Business use only 29