GMPKit

Use our toolkit to start and scale the right way so that your operations are safe, compliant and on schedule. We all want safe and compliant GMP Manufacturing that starts on time, ends on time, is deviation free and has complete and accurate documentation. However, the need to start up, scale up, or transform will always disrupt the steady state. These changes increases the risk that something can and will go wrong. These risks come in three areas: Business Risk: Business risks can Include delays, rework, deviations, lost batches, backlogs, regulatory compliance problems, and even in a worst case the loss of your company's right to operate. Employee Risk: Change fatigue can impact employee morale. The constant need to "build the airplane while flying it" can be exhausting to employees, people can become overwhelmed, and this can lead to burn out and attrition. Compliance and Patient Risk: Starting up and scaling up should never compromise quality. Your patients depend on good manufacturing and patient safety should never be compromised during times of change and transformation. Let GMPKit be your guide: We believe that you should never have to choose between flying the airplane and building the airplane. With the right training and tools you can do both. GMPKit is toolset developed through thousands of hours starting up, scaling up and transforming front line cGMP Manufacturing and Quality Operations. These are not generic LEAN tools targeted at a mass audience. Our concepts have been field tested and proven in high throughput biologics and cell therapy formats. They are easy to learn, easy to use, and can help you stabilize, optimize and take your GMP production to the next level. Learn more at https://gmpkit.com