Quality Risk Management (QRM)
Risk management is an integral part of the system of control and governance. Quality Risk Management protocol and related procedures defines methods to assess, control, communicate and review the risks. The application and execution of risk management within the company is dependent on the degree of impact and risk to the design, development, manufacture and control and supply of products for human use.
An effective quality risk management is performed based on defined procedure (SOP No: ZWI409590) to ensure the high quality drug product is provided to the patient by proactive means to identity and control potential quality issues during development and manufacturing.