Lean Manufacturing in the Pharmaceutical CGMP Environment

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Lean manufacturing has been successfully deployed in the auto industry, in the manufacture of motorcycles, in mattress manufacturing, in the production of tires, and even in the service industries. All these sectors and industries had their own way of doing things before latching on to lean manufacturing techniques. The chief difference between these and the pharmaceutical industry is that the pharmaceutical industry’s “way of doing things” is, and has been for a long time, more firmly entrenched.

Manufacturing in our industry still takes place largely in an environment of current good manufacturing practice (cGMP). And the focus of cGMP is on ensuring that manufacturing produces safe and effective products, which means a host of processes that have to be thoroughly documented, including documentation for both technical standards and operational procedures. The fear has been that, with the pharmaceutical emphasis on regulatory compliance and technical dependability, it will just be too difficult to implement this solutions in a cGMP environment.

The twin pillars of lean manufacturing are elimination of waste and creation of value-within the context of ongoing and continuous improvement. Paradoxically, lean manufacturing involves a set of solid objectives and rigidly documented processes carried along on the current of adaptability directed by newly discovered places for improvement and by customer demand. The challenge for pharmaceutical companies, then, lies in determining how to implement lean solutions in a cGMP environment that really isn’t amenable to necessary short-term improvements and changes.

The four principles that govern any lean manufacturing system are: 1) clearly defined relationships with direct communication; 2) a scientific methodology for implementing improvements; 3) a standard for all work; and 4) a pathway that ensures simple and direct flow. So the job for this consultants is convincing companies that they can and then helping them to put these principles in place alongside cGMP.

In the lean manufacturing process, there is a very direct supplier-customer relationship and tools and methods in place to ensure clear communication, which serves to keep products flowing along the production process and cycle time consistent. But in a pharmaceutical cGMP environment, various departments are usually discrete and siloed, and quality governs cycle time. An effective lean manufacturing implementation in this industry would have to give equal importance to quality and cycle time.

Lean uses a scientific methodology in its quest for total quality. The pharmaceutical industry, however, has generally been reactive in nature-that is, when something goes wrong, only then is action taken to fix it and make necessary improvements. It has been suggested that what’s needed here is for pharmaceutical companies to embrace the FDA’s risk-based approach.

With respect to a standard for work, lean manufacturing and cGMP are more closely aligned. It still remains, though, for pharmaceutical companies to effect a full implementation of lean solutions when it comes to operational procedures.

In the cGMP environment of the pharmaceutical industry, there is already a direct product pathway. The problem, though, is that it’s far from simple because of batch production. Consultants have advocated an effort to move from traditional batch manufacturing to a greater emphasis on single-unit flow.

The pharmaceutical industry, because of its cGMP environment, has been pretty shy about meeting lean manufacturing solutions. Good lean manufacturing consultants have the knowledge and skills to introduce them and nurture a relationship. And it could very well turn into a fruitful and long-lasting marriage.