Consulting, Compliance and Validation
Archive for March, 2019
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Risk analysis, is it time for a change of mentality?
In Europe, the development of risk analysis in the pharmaceutical sector took its first steps in 1998, as an appendix to the Gamp (Good automated manufacturing practice) guidelines. The fifth revision of the Gamp guidelines clearly states that “the application of quality[…]
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If validation becomes faster and easier, the advantage for the pharmaceutical company is considerable
The long time required for compulsory ministerial validation is a handicap for the pharmaceutical industry, which needs to introduce quickly its product into the market. On the other hand, properly performed validation is necessary to guarantee the integrity and safety of the[…]
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