New guidance in 2016 under the auspices of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) will go a long way toward ensuring data integrity throughout the processes of testing, manufacturing, packaging, distributing and monitoring medicines. Ultimately, the goal is to encourage current good manufacturing processes (cGMPs) globally.
In recent years, industry has squarely fixated on the word “current.” It’s not enough for pharmaceutical companies to understand basic data integrity principles: to avoid deficiencies and possible penalties, they must embrace the most current technologies available today. Otherwise, it will be increasingly difficult to comply with enhanced data integrity requirements and prevent lapses.
To ensure that labs are current and in line with good data governance practices, they must achieve excellence in seven core areas.
Below is a review of those seven key areas and the current technologies that the most up-to-date industry players are deploying.
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