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Top 5 Pharmaceutical Manufacturing Trends in 2020

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Top 5 Pharmaceutical Manufacturing Trends in 2020 2 Data integrity and connectivity is becoming more conspicuous in regulated product development. To say that the U.S. Food and Drug Administration (FDA) is perturbed by life sciences companies attempting to pass off incomplete or manipulated data in application submissions would be an understatement. According to a Deloitte report, data integrity violations account for over 70% of the warning letters issued globally. 1 Data integrity has long been in the regulatory spotlight. However, the situation is not improving. With the recent data integrity violation cases involving high-profile companies, the regulatory watchdog is compelled to further ramp up its oversight and action regarding the data management efforts of pharma companies. 2 In response to the discovery of manipulated data in a compliance application, former acting FDA Commissioner Ned Sharpless said "the agency relies on truthful scientific data to make regulatory decisions, and we take the issue of data integrity very seriously." FDA Emphasizes "Complete" Data To be confident that no corners are cut or data is falsified in the development of a drug product, the FDA expects manufacturers to ensure that all data meets these guidelines: attributable, legible, contemporaneous, original, and accurate (ALCOA). 3 Some of the common data integrity infractions cited in warning letters include: • Omitting, editing or deleting data. • Including only passing results in the data presented for batch review. • Sampling or retesting to achieve a specific result or to overcome an unacceptable result. • Failing to retain original raw data. • Backdating record entries. Despite the different variations of these violations, they all involve incomplete data. 1. The agency relies on truthful scientific data to make regulatory decisions, and we take the issue of data integrity very seriously. – Ned Sharpless, Former Acting FDA Commissioner According to a Deloitte report, data integrity violations account for over 70% of the warning letters issued globally. 70%

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