Chimica Oggi-Chemistry Today
Agro FOOD Industry Hi Tech
p. 2-3 / EDITORIAL
Are Toyota’s manufacturing practices the right benchmark for the pharma?
Member of Chimica Oggi / Chemistry Today Scientific Advisory Board
EPCOT International, 29150 Bryce Road, OH 44124, Pepper Pike, USA

Many articles have been written about applying Toyota’s manufacturing practices (1) to the manufacture of drugs and medical devices and value they bring. Benchmarking against what has been successfully applied definitely has value. I believe that Toyota practices have value to industries where precisely “pre-defined” quality items are assembled to produce a product. However, blind application of Toyota’s practices to businesses where chemical reactive processes produce the final product and/or by blending various chemicals to produce a single dose makes me wonder are we really comparing same or similar practices or are we just going through the motions hoping some value will be realized. To me such benchmarking is significant waste of resources and money.

Based on the information in the public domain, it would be worth understanding what happens at an auto assembly plant vs. an API manufacturing or a drug formulation facility or a device assembly facility. Understanding will give us a better comparison perspective. Drug discovery and device manufacture are not part of the discussion.

Autos are assembly of predefined and approved quality components to create a safe product. Pharma is not an assembly but a combination of manufacture of an active pharmaceutical ingredient through reactive processes and its formulation to produce a dose that has to meet defined quality and performance standards.

Comparison of just two areas (supply chain and waste) shows differences. Toyota methods incorporate use of “just in time (JIT)” methods to minimize parts inventory. Supplied parts meet defined quality specs and are not re-tested. Streamlined supply chain is the way of life.

In pharmaceuticals concept of JIT is most likely not understood. If it were understood, regulations would not be asking for re-testing of materials. Why did these regulations come about? Only explanation can be repeated mistakes of cross mixing materials in the manufacture of products and/or use of materials that influenced final product quality.
Regulatory compliance becomes a challenge and significant investment is needed to correct mistakes. It has resulted in ban of import/export (2) of products. Under the current pharma model JIT concept does not work. Inventory turns are generally below 3 compared to automobile average of around 11. Pharma’s low turns impact cash flow and the added costs are passed on to the patients. Pharma manufacturing model is very different from any other manufacturing model and significant revamp would be needed to achieve higher inventory turns.

Toyota system suggests waste reduction, improved people and product flow management (safe) practices. Waste reduction in every business, manufacturing or service, are of great value. It impacts profitability in many ways.

Due to nature of the chemicals used and produced in pharma their flow and personnel interaction safety considerations are an integral part of the process design. Some might consider that waste reduction in pharma manufacturing is given a high priority. I would beg to disagree. In the API manufacturing component of the pharmaceutical manufacturing yield improvement and reduction of number of solvents used is generally not part of the thought process. Reason and rationale for the comment is that the waste generated due to these inefficiencies is part of the current practices and every related...In order to continue reading this article please register to our website – registration is for free and no fees will be applied afterwards to download contents.

Teknoscienza Mobile
Teknoscienze - Viale Brianza 22, Milano - ITALY - P.IVA 06817720151
Teknoscienze S.r.l. © 2012 - tutti i diritti riservati - web terms & conditions - privacy - Credits