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Any departures from pharmaceutical quality are called deviations and can occur at any point during a process or product lifecycle. Deviations can impact system integrity, product quality and public health and safety.
While regulatory requirements are firmly established for the industry with various technology and experience levels, the aim, however, is always to achieve quality. If quality is built into every process, then compliance will come naturally. A company’s culture is a crucial parameter when it comes to deviation and CAPA management, and the establishment of a quality culture starts right at the top and is shared by everyone in the organisation. (@PharmaScholars)
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