Supporting a New GMP Facility Startup for a Growing 3PL Provider A third-party logistics (3PL) provider supporting pharmaceutical manufacturers opened a new facility in Pennsylvania, requiring GMP-compliant qualification and temperature mapping to support regulated operations. To meet startup timelines and regulatory expectations, the facility required initial Performance Qualification (PQ) temperature mapping for controlled room temperature (CRT) and refrigerated environments […]
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21 CFR PART 11 COMPLIANCE ASSESSMENT
Based on the increased use of computer systems in the pharmaceutical industry,the United States Food and Drug Administration (US FDA) issued the 21 CFR Part 11regulations in March of 1997. This regulation provides the criteria for acceptance bythe FDA, under certain circumstances, of electronic records, electronic signatures,and handwritten signatures executed to electronic records as equivalent […]
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