Some definitions of deviations according to different regulatory organizations and requirements are as follows. The deviation definition can vary slightly depending on the regulatory authority and requirements governing the company’s processes. In the pharmaceutical industry, deviations can occur during drug product development, manufacturing, labeling, packing, sampling, testing, storage, distribution, and other processes. What Is the Role of Deviation Management Software in Streamlining the Deviation Management Process?Ī deviation is any departure from approved processes, procedures, instructions, specifications, or established standards.What Is a Deviation Management Process Flow?.What Are the Deviation Management Guidelines in the Pharmaceutical Industry?.How Are Deviations Categorized Based on Risk?.What Are the Different Classification Types of Deviation?.The following topics are further discussed in this article:
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