ABSTRACT

The pharmaceutical industry has been intensely regulated due to the quality standards required for the drugs. The introduction of Good Manufacturing Practice (GMP) in the 90’s resulted in a very rigid organizational structure, both in the stage of product development and when manufacturing (Barker 1975, Levchuk 1991): the production process of each drug has to be well defi ned, all important parameters of the process have to be specifi ed, and each manufacturing run has to be carried out similarly to the original (and approved) process (Donawa 1995).