Lean Manufacturing in Pharmaceutical cGMP environment


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

Manufacturing in our industry takes root. Yet for the most part the Environment current good manufacturing practice (cGMP). And the focus of cGMP is to ensure that production produces safe and effective products, which means a host of processes that have to be thoroughly documented, including documents for both technical standards and practices. The fear has been that the pharmaceutical focus on regulatory compliance and technical reliability, it will just be too difficult to implement these solutions in a cGMP environment.

The twin pillars of lean production are the waste and the creation of value-in the context of ongoing and continuous improvement. Paradoxically, lean manufacturing includes a set of solid targets and closely documented processes carried out by the existing adaptive directed the newly discovered areas for improvement and customer demand. The challenge for pharmaceutical companies, then lies in determining how to implement lean solutions cGMP environment that really is not possible to reform the necessary short-term and changes.

The four principles applicable to all lean production system are: 1) clearly defined relationship with the direct communication; 2) scientific methodology for implementing improvements; 3) Standard for all the work; and 4) a process that ensures a simple and direct flow. So the job for this consultant is convincing companies that they can then help them put these rules in place along with cGMP.

In lean manufacturing, it is very direct supplier-customer relationship tools and methods to ensure clear communication, which serves to keep goods flowing along the production process and cycle time, however. But pharmaceutical cGMP environment, various departments usually discrete and siled and quality control cycle time. Effective implementation of lean production in this industry would have to give equal emphasis on quality and cycle time.

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

With respect to the standard for work, lean production and cGMP in better compliance. Is it still, however, for pharmaceutical companies to come to the full implementation of lean solutions when it comes to working.

The cGMP pharmaceutical industry environment, there is already a direct product of the process. The problem, though, is that it is not simple for batch production. Consultants have advocated an attempt to move from the traditional batch production to more emphasis on one unit flow.

The pharmaceutical industry, for cGMP environment, has been somewhat shy to meet lean manufacturing solutions. Good lean manufacturing consultants have the knowledge and skills to introduce them and cultivate the relationship. And it could very well turn into a fruitful and long-lasting marriage.


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