GxP is a bunch of quality guidelines and benchmarks designed to ensure that your products are safe for patient use and adhere to quality standards consistently. GxP applies most readily to pharmaceutical and biopharmaceutical organizations through the requirements of USFDA 21 CFR Part 210 – 211. List of GxP Compliance Checklist People 1. Are all…
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to disruptive innovation, from batch to continuous processing, from bulk processing to personalized medicine, from centralized systems to the Internet of Things (IoT), from…
GMP stands for Good Manufacturing Practices. It is a set of guidelines and regulations to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate for their intended use. This includes guidelines for the design, monitoring, and control of manufacturing processes, as well as quality control testing procedures. GMP compliance is…