Product development supporting issues

ISO 9000. The ISO 9000 series of standards was first issued in 1987 and then updated in 1994. The ISO 9000 standard describes the selection criteria for the four standards, ISO 9001—9004. ISO 9001 is composed of 20 items covering manufactured products from design and development in R D to commercial production and after-sale service or technical support. ISO 9002 has 19 of the items in 9001 describing the requirements of a quahty system for the manufacture of an item, such as chemicals, to a specification only the requirement relating to product development is omitted. Chemical companies seldom certify to ISO 9003, which describes the quahty system for a laboratory involved in final inspection and test. Finally, ISO 9004 presents guidelines for total quahty management. 

In general, progress in drug development depends on data obtained from analytical instruments. Thus, how this information is derived and provided to decision makers is critical to the success of the pharmaceutical industry. LC/MS technologies have effectively and uniquely supported the productivity (quantitative processes) and efficiency (qualitative processes) needs of drug development. Future issues appear to be directed toward enhancement of the information-gathering process that focuses on the relationship between data and decision (Table 8.1). 

Being first on the market with a pharmaceutical product is of major business importance. Because speed is a major issue, many technical issues (i.e., corrosion) are frequently "over engineered" from the standpoint of good engineering practices. This allows flexible equipment to be capable of handling varied conditions and chemistries to support rapid product development. This then limits the need for corrosion testing of all processes. 

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