CI and QbD

The FDA initiated the drive for continuous improvement in the pharmaceutical industry in 2004, attempting to unite the industry in a drive for better business practices, and more streamlined enterprises; reducing waste and recognizing opportunities.

In organizations without a CI initiative, you are likely to find extreme variability in operations, often impacting the quality of products and interactions with clients, patients, and customers. It is from this type of situation that both the desire for continuous improvement and the uptake of quality-by-design development was sparked.

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QbD development is based upon the theory of Joseph M. Juran, who identified a need to establish goals, define target markets, and discover their needs. Someone following this method would then begin developing and refining features and process controls based on their research.

Late starters to continuous improvement

Of all manufacturing industries, the pharmaceutical industry was one of the last to fully embrace the concept of continuous improvement. Initiatives such as Six Sigma and the larger drive for OPEX have yielded strong results in the past two decades, and now, CI as a universal concept has been common parlance since around 2012.

See also: pre-clinical discovery, lean, and the benefits to your enterprise.

Part of the reason for the slow uptake by pharmaceutical firms has been the (highly-successful) drive to get products into trial as soon as possible. This created great products, but under-optimized processes, and now the slack is being rapidly picked up. This process may be painful for many firms, as the tried-and-true methods of the past thirty years or so have been extremely successful. CI in pharma is a drive to stop diminishing returns on outmoded systems of business.

Many firms, such as Pfizer, have been working on improving their manufacturing process since the turn of the century. They have implemented Six Sigma, Lean, and Agile systems and have been praised for their ‘five pillars’ system. Here at Pharma IQ, we have adapted that model into the infographic shown below.

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Processes, batches, and new approaches to CI

A vast number of pharmaceutical firms have manufactured primarily by batch, which has bypassed the need for continuous processing. Reluctance to change has sprung from over-familiarity with old processes, the risk of contamination, and over-regulation prohibiting any trail blazing.

Looking at the successes of other industries, the pharmaceutical industry will continue to improve its efficacy, reduce its capital costs, increase how reliably it functions, and eventually bring new products to market even quicker than at present. According to the Pharma Times, the most important marker of progress will be the speed with which companies are able to assess how viable a product is – potentially saving time and capex, reducing the financial costs to the company, and the human cost of wasting additional time researching a doomed venture.

If you enjoyed this article, and want more on CI in the pharmaceutical industry, why not listen to our effective CI podcast?