How are deviations defined?

12.07.2021

Question of the Week

There is no universal definition for the term "deviation". Each company must therefore determine for itself what is meant by deviations. Usually, this includes at least violations of limits in processes of manufacturing and testing as well as other systems and procedures. The organisational forms and responsibilities within deviation management are also defined on a company-specific basis.

[GMP Compliance Adviser, Chapter 1.E

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