3 . C O N T I N U A L I M P R O V E M E N T O F P R O C E S S PERFORMANCE AND PRODUCT QUALIT

This section describes the lifecycle stage goals and the four specific pharmaceutical quality system element that augment regional requirements to achieve the ICH Q10 objectives , as defined in Section 1.5 .For product discontinuation , a pre-defined approach should be used to manage activities such as retention of documentation and samples and continued product assessment ( e . g . .Complaint handling and stability ) and reporting in accordance with regulatory requirements .