Hey guys we have talk about IQ, OP and PQ about Syringe Filling Process – filling syringes with an injectable bone void filler and Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft. Now I have a question about the CGMP (current good manufacturing practice) in manufacturing this two devices. We know that CGMP is a Regulations enforced by the US Food and Drug Administration (FDA) that provide for systems to assure proper design, monitoring, and control of manufacturing processes and facilities. What are you input about the CGMP for this two devices that you have come across on your job? I haven’t had no experience and hopefully someone has. All your input would be appreciated