2023年4月14日 · GxP compliance demands airtight processes and appropriate tools. This guide gives you everything you need to know to overcome the challenges of GxP compliance and embed robust long-term GxP into the heart of your business.

2024年7月1日 · Computerized systems that use GxP processes require validation of adherence to GxP requirements, and are considered qualified when the system can demonstrate ability to fulfill them. Azure can help you meet your GxP requirements and regulations enforced by the FDA under 21 CFR Part 11.

GxP is about controlling the processes by which these products are developed, manufactured and handled in defined ways throughout the supply chain - ensuring they are of consistent quality and can be used as intended by consumers: Documentation, Communication, Traceability and …

2025年3月26日 · GxP stands for Good "x" Practices, where "x" refers to specific areas like manufacturing, distribution, laboratory, and clinical processes. Together, these standards ensure that organizations follow validated procedures, maintain proper documentation, and produce reliable, reproducible results.

GxP is essential in research laboratories for maintaining the accuracy and reproducibility of experimental data. Beyond guaranteeing regulatory compliance and ensuring data integrity, GxP streamlines processes and documentation management, improvers operational efficiency and facilitates audits.

2023年8月8日 · GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations in many different fields. What is GxP?

2024年9月12日 · GxP, an acronym for Good [X] Practices, serves as the cornerstone of quality and regulatory compliance in the pharmaceutical and medical device industries. But what exactly does this involve?

This Guide provides guidance and examples on the application of the principles and framework of GAMP 5 (Reference 15, Appendix 13) to a wide range of GxP regulated process control systems.

GxP encompasses several key practices, each focusing on a specific area of pharmaceutical operations. Here are some of the core components of GxP: GLP establishes quality systems and controls for non-clinical laboratory studies.

2024年11月8日 · GxP mandates that manufacturers are responsible for ensuring that all activities related to production, control, storage, and distribution of medical products comply with GxP regulations. This includes testing raw materials, documenting processes, and performing quality checking as well as training personnel involved in the production process.