A GMP Manufacturing
Operations Managment Toolkit
Unlock your batch disposition pipeline with right-first-time manufacturing, streamlined record review, rapid failure investigation and visual lot disposition tracking.
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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 and your patient population is the need to
- execute right first time
- review production records
- thoroughly investigate and correct failures
- test the product
- organize all of this data in the batch disposition process.
This process can become very complex 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 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 will pose challenges for front-line operations and quality assurance teams.
When it is time to start up, scale up, or transforming GMP manufacturing, the risks tend to manifest in three ways:
Business Risk
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.
Employee Risk
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
Patient Risk
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
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.
Our Approach
Between the plant capacity and your patient demand are four common bottlenecks in the batch disposition pipeline.
Our toolset will help you:
Right First Time Manufacturing
Deploy an operations management framework to reduce failures related to execution error during production.
Batch Record Review Optimization
Streamline review, track corrections, achieve turn around times and improve throughput.
Failure Investigation and CAPA
Implement a structured problem solving approach to increase investigation quality and speed.
Visual Batch Disposition
Visualize your disposition data so that your teams can prioritize action, anticipate and resolve delays before they become a problem.
Get Started With GMPKit
Connect with us or deploy our online tools through the GMPKit store:
GMP Consulting
We can help your team deploy an operations management strategy, , provide interim leadership coverage, Person in Plan (PIP) services, prepare for inspection, or help out with a complex technical problem.
Online GMP Training
Tap into our 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 more about biotech basics, operations leadership and how to open up your disposition pipeline:
