organisation behaviour

Continuous Processing in Pharmaceutical Manufacturing
Matthew J. Mollan Jr., Ph.D. and Mayur Lodaya, Ph.D., Pfizer Inc.
1.0 Introduction
Pharmaceutical processing in the manufacturing environment is synonymous with batch processing in the sense that each unit dosage form is identified by a unique batch. This simplified tried and true approach has been used for decades as it served well for both the industry and the regulatory bodies. In comparison, other industries that also produce and process materials, such as petrochemical, chemical, polymer, food etc., have steadily moved to continuous processing technologies in manufacturing, driven mainly by cost and quality considerations. A recent article [1] comparing batch vs continuous processing discussed some examples of the reason, other than tradition, why the pharmaceutical industry is dominated by batch processing. The lack of flexibility in batch processing to respond to increasing levels of growth was cited as the primary driver for why other industries have moved to continuous processing technologies. Other goals that influence the decision to move from batch to continuous processing included the desire to minimize the required size of new manufacturing plants, as well as the need to efficiently use the available capacity [1]. Recently, both the pharmaceutical industry and the FDA agreed that an overhaul of the manufacturing regulations that apply to innovative processing methods will prove beneficial for the patient that both of them serve [2]. A highlight of this was illustrated in a recent article in Wall Street Journal [3], which provided a description of how the industry and the FDA are working together in several joint initiatives to apply new quality testing methodologies.
Historically, pharmaceutical companies have competed solely on the basis of innovation through new drugs for medical needs. A recent review of drug development costs stated that capitalizing out-of pocket costs to the point of…