Jyrki Heinamaki

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Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part II: Expert Opinions

Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part II: Expert Opinions

Jukka-Pekka Mannermaa;Jyrki Heinamaki;Marjo-Riitta Helle
August 1st 2003

European expert opinions regarding pharmaceutical process validation were collected and studied by performing an Internet Delphi survey. In total, 36 experts from 10 countries representing the pharmaceutical fields of industry, regulation and academia participated in the survey. The overall attitude to process validation appeared to be positive; however, a number of concerns were raised. More education, better use of prioritizing tools and increased evidence of cost-effectiveness is needed to further develop and facilitate process validation.

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