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As mentioned in the first blog of our Lean Manufacturing Series, lean allows companies to meet FDA regulations and thrive in an increasingly competitive market. The lean model is becoming prominent in the Life Sciences industry. It is mandatory that companies adhere to CGMP standards. As a lean model does not make a company more CGMP compliant or better able to meet CGMP principles, it does, however, assist in meeting CGMP standards. Lean eases the production process by saving both time and money through the reduction of error and waste.

Core principles of Lean Manufacturing

  • Continuous Improvement – This is lean manufacturing’s base principle. It is essential for a company to commit to unceasing innovation in order to flourish within the industry’s manufacturing landscape.
  • Elimination of Waste – The removal of error from the manufacturing process improves a company’s productivity and enhances its profitability. Waste can occur from overproduction and excess inventory due to production defects. Eliminating these forms of waste requires a company to carefully review its manufacturing processes.
  • “Just-In-Time” Production – Producing exactly what is needed when it is needed goes hand-in-hand with leveled production; the foundation of lean. By taking future forecasts and production history into consideration, product manufacturing can be managed with a simplistic process on a daily basis.
  • Built In Quality – Embedding quality at every stage of the manufacturing process, from research, synthesis, design, warehousing and shipping, ensures mistake-proof production. To that end, proper equipment maintained to the highest standards is imperative.

Core Principles of CGMP

High Quality Drug Production – The FDA’s CGMP regulations are designed around the responsibility manufacturers in the Life Sciences industry have in terms of sustaining the public’s trust in credible products.

Efficiency and Purity – FDA rules call for systems that can guarantee proper design, monitoring, and control of the manufacturing process from start to finish.

Regulated Standards – Drug products meet quality standard when the following measures are properly put into practice:

  • Have a strong quality management system in place
  • Have the capability of procuring top quality raw materials
  • Establish robust operating procedures
  • Detect and investigate product quality deviations
  • Maintain reliable testing laboratories

These processes eliminate confusion, contamination, deviations, and failures.

Lean Manufacturing and CGMP

The FDA established CGMP regulations in order to provide manufacturers the flexibility to independently decide the necessary controls for their best implementation. This flexibility of CGMP regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. A streamlined manufacturing process reduces both error and waste, while also having the ability to change and adapt to production demands. In a lean pharma manufacturing environment, CGMP and lean manufacturing are equal partners; working together to reach maximum efficiency. Companies should embed both CGMP standards and lean principles into their manufacturing processes and corporate culture.

The FDA is actively involved in funding and supporting efforts for lean manufacturing. Lean allows corporations to meet production targets in a much more efficient manner. It is a proven method that when in sequence with the FDA’s CGMP regulations, lean reduces costs, eliminates waste, maintains high levels of quality, and increases productivity.

Our next blog in this series will discuss how Enterprise Asset Management (EAM) drives lean manufacturing. Stay tuned!

Sources/Additional Information:

“Lean and Mean: How Does Your Supply Chain Shape Up?” by Knut Alicke and Martin Losch, McKinsey & Company

http://www.pharmtech.com/lean-manufacturing-practice-cgmp-environment

http://www.lean-manufacturing-junction.com/lean-manufacturing-principles.html

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

http://www.automationworld.com/batch-manufacturing/new-pharma-factory

https://pharmout.net/downloads/white-paper-10-problems-with-pharma-plant-maintenance.pdf

http://www.pharmtech.com/lean-manufacturing-practice-cgmp-environment

https://pharmout.net/downloads/white_paper_lean_pharma_manufacturing.pdf

http://searchmanufacturingerp.techtarget.com/definition/enterprise-asset-management-EAM

http://www.reliableplant.com/Read/25421/EAM-managing-sustainability-industries

http://www.genesissolutions.com/effective-asset-management-enhances-lean-manufacturing-principles-and-processes/

http://www.lean.org/WhatsLean/