GXP

Audit Forum #1: Preparing For Remote GMP and GDP Audits

INTRODUCTION Since the beginning of the Covid-19 pandemic, business life has changed. There is a reluctance to travel.  Companies are reluctant to have visitors on site. There has been a significant increase in employees working from home.  There have also been increases in having meetings held virtually.  This has resulted in a significant reduction in company audits by customers and regulatory agencies.  As such, many new issues have arisen in both how these audits are conducted for both good manufacturing practices (GMP) and good distribution practices (GDP) audits. ...

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