Pharmaceutical products lifecycle

Those seeking to develop therapeutic products will need to understand these dynamic interactions and the consequent potential changes in one or more society s approach to its healthcare. Indeed, this is another opportunity for pharmaceutical medicine to broaden. The speciality should cover all pharmacologically active treatments, all disease preventions and all health maintenance modalities. The objective is to maximize patient benefits and extend product lifecycles, as well as company sales. Clearly, pharmaceutical medicine requires an ability to read the direction society is taking and an understanding that, on a global basis, various... 

Pharmaceutical companies have attacked the problem from both ends. We mention briefly here that efforts to expand markets, reduce price controls, extend product lifecycles, and to shrink time to market, regulatory burden, and follow-on studies are key strategies for the pharmaceutical industry. The focus of this discussion however, is on the complementary issue of pharmaceutical R D itself. 

Pharmaceutical and healthcare companies that invest in compnteiized systems need systems that are delivered on time and within bndget, and that fnUull bnsiness fnnctional and performance requirements. In their rush to place new prodncts and versions on the market, however, computer software and systems suppliers rarely deliver error-free products. In fact, some two thirds of lifecycle costs can be incnrred after delivery of the software and system to the users. Pharmaceutical and healthcare companies do not want lots of downtime, disruption, and escalating costs once a system has been delivered and implemented. And, of conrse, in GxP applications, any deficiencies will be of particular interest dniing regnlatory inspections. 

ICH Q9 describes how QRM principles—used extensively in other industries—can be applied to the pharmaceutical industry throughout the lifecycle of a product. The primary objective of risk management as it applies to the pharmaceutical industry is that risk to quality should be defined based on scientific knowledge and ultimately linked to the protection of the patient. 

ICH QIO illustrates a model for a pharmaceutical quality system that can be implemented throughout the lifecycle of a product. This primary objective is achieved through the implementation of three specific goals, including (1) establish, implement, and maintain a system that ensures the delivery of high-quality drug product with the appropriate quality attributes to consumers (2) develop an effective monitoring and control system that continually assesses process performance and product quality and (3) continually identify and implement... 

The pharmaceutical quality system should be applied throughout all stages of the product s lifecycle, including pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. ... 

---