Pharmaceutical manufacturing future issues

The MCA acknowledges the key role suppliers have in the future of validation and are very keen that the supplier s capability is appropriately assessed (refer to Chapters 14 and 15) complementary support is given by the pharmaceutical manufacturer to ensure all validation requirements are satisfactory covered. Issues that need to managed include the following ... 

Fundamental healthcare issues may also be involved in the situation of policy-driven therapeutic research. The future investment of society in health may require a large-scale national clinical trial to answer questions relating to the prevention of disease or premature death. This type of clinical trial will not simply relate to one manufacturer s product. As such, it is preferable that the trial is organised on a national level, not necessarily with the exclusion of the company(s) involved. An independent data-monitoring committee (IDMC) should oversee the clinical trial with as much support from the pharmaceutical company(s) as possible. The clinical data collected belongs to the state and should be treated with the same quality standards as any pharmaceutical company sponsored study. 

The book concludes with perspectives on future trends and some thoughts on the future direction of LC/MS applications in the pharmaceutical industry. New standards of analytical performance are discussed with regard to throughput and capacity. A prospective look at how higher standards of analytical performance in the pharmaceutical industry will effect relationships with academia and instrument manufacturers is featured. These sections extend the initial thesis of accelerated development to include new analysis bottlenecks and perspectives on analysis issues and industry needs. 

The replacement of chlorofluorocarbon (CFC) propellants with the non-ozone-depleting hydrofluorocarbons (HFCs) merit mention for two reasons. First, it illustrates how environmental impact can be an important selection criterion at a time when green issues are high profile. Second, HFCs were developed and evaluated for safety and delivery capability by a consortium of pharmaceutical companies, with costs shared and evaluation programs defined by prior agreement between end-users and propellant manufacturers. Such collaboration could be employed usefully in the future to develop novel excipients for delivery or targeting. The benefits would undoubtedly accrue to all. 

Projecting market demand for specific classes of therapeutics in development will remain a major planning issue for bio-pharmaceutical companies. The ability to meet the demand for biopharmaceutical production capacity, whether through in-house manufacturing or outsourced contract manufacturing, carries strategic and financial implications. Also, FDA approval policy and the development of the biogenerics market will have a major impact on future capacity requirements (see Part VII, Chapter 4). 

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