GxP in Pharma n Medical Devices Jan2021 by Raaj GPRAC & Pharmaelearning скачать в хорошем качестве

GxP in Pharma n Medical Devices Jan2021 by Raaj GPRAC & Pharmaelearning

GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. G – stands for “Good” P – stands for “Practice” x – variable depending on the application. GMP (Good Manufacturing Practice), GDP (Good Documentation Practice), GLP (Good Laboratory Practice) and many more.Which sector need to adhere to GxP? i.e. . Medical Device Manufacturers In Vitro Medical Devices (IVD) Pharmaceuticals Life sciences. The GxP requirements outlined by the regulating bodies, define the protocol and controlled processes vital to the safety of their end products. For example, How products are consistently manufactured How new technologies are researched How product designs are tested and challenged How laboratory and manufacturing equipment is calibrated and maintained How their processes are traced from start to finish through controlled documentation How different kinds of products are stored and transported How their workers are trained How records of all these processes are captured and maintained to monitor the ongoing effectiveness of these systems This methods will help to: (cont…) Create high performing products of consistent quality in the most efficient way Minimize risk of product failure - proportional to its potential to harm Provide evidence that regulated products are in conformity with regulatory requirements Ensure knowledge is maintained in your organization Establish a mechanism for communication in all levels of your company Achieve accountability across an organization for regulated activity. GxP defines the best practices that cover every part of the life sciences industry and value chain.  All GxP can be seen as subsets of Good Manufacturing Practice (GMP) because they all feed into and support the safe production and delivery of regulated life science products. 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. The central pillars Documentation, Communication, Traceability and Accountability To demonstrate that required controls have been observed and ensure potential non-conformance in end products can be identified and corrected Data integrity is key Knowing that data and documentation is accurate, up-to-date and accessible (and that they cannot be changed or tampered with) gives a high level of confidence to companies and regulators Good Documentation Practices (GDP) are central to all GxP s of GxP. The 5 Ps of Good Practices The 5 -S of Good Practices