Deviation

Deviations and Nonconformities in Pharmaceutical Industry

Deviations and Nonconformities in Pharmaceutical Industry

“Deviation” terms used in the pharmaceutical industry, while the term “non-conformance” is classically used in the medical devices industry (ISO 13485:2016). Nonconformity Nonconformance means that there was an event with a process, service, or product, and the result does not match the requirements. ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.” According to FDA…

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