Right First Time Manufacturing & Streamlined Disposition
Managing front line operations in the GMP biopharmaceutical manufacturing space involves a complex process executing under very specialized quality and regulatory requirements.
Between your plant capacity (the people, methods, materials and equipment) and your patient population are the need to execute with a high level of reliability, review production records, thoroughly investigate and correct failures, product testing, and organizing all of this data in the batch disposition process.
The problems with the plan are revealed when you start up or scale up.
Business Growth Disrupts Steady State Manufacturing:
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 the organization disrupts the steady state.
Business changes needed to start and scale always increase the risk that something will go wrong. Is your operations team equipped for the risks associated with the business plan?
The Problem with Starting/Scaling GMP Manufacturing
Growth is a necessary part of the business plan, but starting-up and scaling-up GMP Operations will pose challenges for front-line operations and quality assurance teams.
When it is time to start up, scale up, or transform GMP manufacturing, the risks tend to manifest in three ways:
Business risks include delays, rework, deviations, lost batches, backlogs, and regulatory compliance problems. In a worst case scenario your company can lose the right to operate.
Change fatigue can impact employee morale. The constant need to be "building the airplane while flying it" can be exhausting to employees. People can become overwhelmed and this can lead to burn out and attrition
Starting up and scaling up should never compromise compliance. Your patients depend on quality manufacturing and patient safety should never be compromised during times of change and transformation.
Your Operations and Quality Leadership Teams Need A Plan
Managing complex changes in the GMP space is much easier when your team is equipped with the proper change strategy, tools and training.
The GMPKit team can help you with this.
Let Us 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 in place your team can start up and scale up in a way that is planned and predictable.
GMPKit is toolset developed through thousands of hours starting up, scaling up and transforming front line cGMP Manufacturing and Quality Operations in biologics and cell therapy manufacturing.
These are not generic LEAN tools targeted at a mass audience. The concepts we use have been field tested and proven in high throughput clinical and commercial cGMP operations.
Our toolset is easy to learn, easy to use, and can help you stabilize, optimize and take your GMP production to the next level.
Between the plant capacity and your patient demand are four common bottlenecks in the batch disposition pipeline.
Our toolset offers solutions for each:
Right First Time Manufacturing
Our operations management framework can reduce failures related to execution error during production.
Batch Record Review Optimization
Our software can help you streamline review, track corrections and improve throughput.
Failure Investigation and CAPA
Use a structured based problem solving approach to increase investigation quality and speed.
Visual Batch Disposition
Our visual disposition software can interpret your native systems so that your teams can anticipate and resolve delays before they become a problem.
How To Get Started With GMPKit
Click the buttons below to learn more about how to unlock your batch disposition pipeline.
We can help your team deploy an operations management strategy in 120 days, provide interim leadership coverage, Person in Plan (PIP) services, or help out with a complex technical problem.
Online GMP Training
Tap into our every growing library of online training and resources directed at unlocking the four common lot disposition bottlenecks. Click the button below to see how we can train your team.
Software & Tools
GMP documentation and inspection readiness does not just happen on its own. Operations managers need tools to track status, drive results, and quickly identify and remediate risks.
Learn More on the GMPKit Blog
Check out the blog to learn how to use the blueprint and apply it to leadership development and risk mitigation in biologics and cell therapy manufacturing.