Facilities in Eastern Europe – An ISPE publication
This fascinating Case Study describes the highs and lows of designing and constructing a new pharmaceutical production facility, to West European standards, in Bulgaria. In this article Austin sets out how it dealt with cGMP, regulatory issues, construction time, quality, available materials, codes, culture, contractual ethos and language. A steep learning curve for all parties was necessary to create what has turned out to be an impressive facility that stands as a benchmark in East Europe.
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