Volume7,Issue1

Every organization should have a written standard operating procedure (SOP) establishing the provisions for corrective and preventive actions. Instructions for how they should be handled within the organization in case of potential product problems, customer complaints or action to eliminate the cause of a detected Nonconformities or incident. Effective corrective action and preventive action (CAPA) systems are a key component to continuous improvement. This review provides a comprehensive view on steps involved in corrective action and preventive action, mechanism of taking CAPA enabling to improve the system of quality management and Application of CAPA System throughout the Product Lifecycle in pharmaceutical industry, and it is importance to establish change management system after CAPA which provide a high degree of assurance there are no unintended consequences of the change.

The purpose of this review article is to discuss different ways for success of technology transfer. This article highlights the goal, methods, importance and various models associated with technology transfer and steps involved in the process of technology transfer. This is an attempt to understand the aspects related with technology transfer. The transfer may be said to be successful if the receiving unit and the transferee can effectively utilize the technology for business gain. The transfer involves cost and expenditure that should be agreed by the transferee and transferor. The success of any particular technology transfer depends upon process understanding or the ability to predict accurately the future performance of aprocess.

“Quality metric” is the measure of the effectiveness of systems associated with the manufacture of pharmaceutical products, including the pharmaceutical quality system. This is widely used in industry and they are potentially used to reduce drug shortages and it is the common language to gauge progress around quality. Quality Metric may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints and many other internal and external processes. It should focus on effectiveness and measure that the right things are being done correctly. Quality Metrics are difficult to establish but provide excellent insight into the health of the quality system ,the use of quality metric data leads to further development of FDA’S risk based inspection schedule and to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, to also improve FDA’S evaluation of drug manufacturing and control operations. It can be used to assist segment sites for risk based inspection schedule and also assist to segment product and individual product manufacturer based on risk. The key points in quality metrics are keep it simple, improve objectively and segmenting sites/products and also evaluating quality systems. Share the quality goals across the organisation and establish quality performance metrics based on linkage to organisational objective