Abstract
It is no secret that the pharmaceutical industry is undergoing rapid and revolutionary change. The impact of managed care and threatened pricing caps by the US Congress on new products has caused many companies to re-evaluate their short and long term business and research strategies. In too many cases, this has resulted in down-sizing by both lay-offs and attrition. For most analytical laboratories, this has meant doing more with less resources. There are several major ‘realities’ that are having a significant influence on the amount and type of analytical support required to bring a new product to the market place in today's regulatory climate. They are pre-approval inspections, the Barr decision and the proposed ICH guidelines. Other realities of the 1990s are also influencing the operation of the analytical laboratory. To cope with these realities, wise use of resources is mandatory. The strategies employed by each company differ, but laboratory automation is usually one of the important elements of the equation. Other elements include contract laboratories, consultants and temporaries. Each of these elements provides part of the solution to doing more with less, but each has its own positives and negatives which must be considered. This paper looks at the relationships between these factors and their impact on the analytical laboratory.
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