732_ Industrial Pharmacy: A Comprehensive Approach approaches at each stage of the lifecycle, so that continual improvement across the entire product lifecycle is promoted. Pharmaceutical Product Development Discontinuation Technology ‘Commercial Transfer Manufacturing The quality risk management and effectiveness of the quality system are related to the type of product and/or manufacturing process. These should be properly understood and the regulatory requirements or approaches should match with all these. The effectiveness of the pharmaceutical quality system is normally evaluated during a regulatory inspection at the manufacturing premises. Potential opportunities to enhance science and risk based regulatory approaches. Regulatory processes will be determined by region. Product life-cycle ICH Q10 guideline has three major objectives which facilitate smooth implementation of regional GMP requirements as well as regulatory requirements. © Product realization: When a system is established, implemented and maintained, it can deliver the products of required quality attributes that can meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers. ‘© State of Control: For desired process performance and product quality an effective monitoring and control systems should be developed and used. Thereby a continued suitability and capability of processes could be assured. Quality risk management can be used to identify the monitoring and control systems. ‘© Continual improvement: Through continual improvement system both process and product quality can be improved, variability can be reduced; thereby innovations and pharmaceutical quality system can be enhanced. Thus, the ability to fulfill quality needs can be increased consistently. Quality risk management is useful for identifying and prioritizing areas for continual improvement. Elements of Pharmaceutical Quality System © Process performance and praduct quality monitoring system: to produce a product of desired quality and to identify areas for continual improvement, the manufacturer should plan and execute a system for the monitoring of process performance and product quality to ensure a state of control. For this implementation of a control strategy, regular analysis of parameters and attributes identified in the control strategy, and identification of source of variations that affect the product quality and process performance are required, Ul O <