GMP Compliance Strategy

Continuous Improvement Consulting Services

Lean Pharma

Our Continuous Improvement Consulting Services approach uses Lean Manufacturing concepts which is a systematic approach to manufacturing and production that focuses on eliminating waste and improving efficiency. It originated in the Toyota Production System (TPS) and has since been adopted by numerous organizations across various industries. Many of the quality processes – like CAPA, QbD, were actually developed in the automotive industry to improve product quality and process efficiency.

The goal of Lean Pharma is to deliver high-quality products to patients while minimizing costs and lead times. However, in the highly regulated world of pharmaceuticals, medical devices and biologicals, one rarely hears of “Lean Pharma”. So the question is: how do you combine Six Sigma, lean manufacturing, 5S and other world class manufacturing techniques with GMP compliance and remain compliant?

Process Improvement Consulting Services

Continuous Improvement Consulting Services

In companies with heavy regulatory compliance requirements, critical business performance indicators such as stock turnover, manufacturing cycle times and QC release times are often well short of the benchmarks of other industries.

Is it possible to combine common continuous improvement tools and techniques in regulated facilities? The trick is to understand how to marry GMP compliance with continuous improvement.

PharmOut has consultants experienced in implementing process improvement in regulated facilities.

We can:

  • Assess your processes and suggest or implement improvements
  • Guide you through the GMP implications of the improvements
  • Manage the whole project, leaving you to focus on your core business, or just provide overview process improvement consulting services
  • Train your staff in process improvement techniques and how to ensure GMP compliance at the same time.

Lean Manufacturing Consulting Services

Lean manufacturing aims to eliminate waste or non-value adding activities in manufacturing processes.

Lean manufacturing combines the principles of: Just in Time, SMED, Value Stream Mapping, Kanban, 5 S and Total Quality, all with the aim of zero paper, zero inventory, zero downtime, zero defects, and zero delays in design, manufacture and distribution.

Now, try doing that whilst ensuring Quality system compliance!

PharmOut’s lean manufacturing consultants have a number of years of extensive experience in introducing such improvement programs in heavily regulated manufacturing environments.

More Information:

If you would like a quote or would need to ask questions, please contact us.

Further Reading:

Want to read more? Why not check out our related webpages or blogs.