GMP Manufacturing 

Unlock your batch disposition pipeline with right-first-time manufacturing, streamlined record review, rapid failure investigation and visual batch disposition.


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Biologics and Cell Therapy Manufacturing Systems

Managing front line operations in the GMP biopharmaceutical manufacturing space typically involves a complex biochemical process executing under very specialized quality and regulatory requirements.

In addition, between your plant capacity  and your patient population are interconnected quality systems that must:

  • ensure that batch records and analytical methods are reviewed
  • detect, thoroughly investigate, and correct failures
  • ensure the product meets the quality standards
  • organize, compile and systematically review batch disposition¬†data

These interconnected engineering and quality processes can become very complex as you scale up to meet patient demand.

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 volume in the interconnected production and quality systems.

The Problem with Starting/Scaling GMP Manufacturing

Growth is a necessary part of every business plan, and the expectation is that as the production system scales, the supporting systems will scale too.  But the reality is that starting-up and scaling-up will pose challenges for front-line operations and quality assurance teams. 

When it is time to start up or scale up your GMP manufacturing systems, 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.  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.

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.

The GMP Kit Approach

Between the plant capacity and your patient demand are four common bottlenecks in the batch disposition pipeline. 

Our toolset will help you:

Improve GMP Manufacturing Reliability

Deploy an operations management framework to reduce failures related to execution error during production.

Optimize Manufacturing Batch Record Review

Streamline review, track corrections, achieve turn around times and improve throughput.

Rapidly Investigate & Correct Failures

Implement a structured problem solving approach to increase investigation quality and speed.

Visualize Your  Batch Disposition

Visualize your data so that 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 Plant (PIP) services, prepare for inspection, or help out with a complex technical problem.

Online GMP Training

Tap into our 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.  

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Software & Tools

GMP documentation and inspection readiness does not just happen on its own.  Operations managers need tools to visualize data, track status, drive results, and reduce 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: 

How To Write the Perfect Problem Statement

May 28, 2024

What is Tangential Flow Filtration?

Aug 26, 2023

What is A GMP Deviation Investigation?

Aug 25, 2023