A few years ago, the pharmaceutical industry was way below other businesses in both, manufacturing efficiency experience and productivity. Pharmaceutical manufacturers were completely reluctant to introduce any changes, mainly due to the high costs of revalidating every process. Soon, inefficiency and waste became predominant, and quality was often significantly affected. The reject percentage rose dramatically to nearly 10%, while other industries, like the semiconductor business remained in a steady 0.0001. After these disastrous results, pharmaceutical manufacturers decided urgently to introduce changes, with one main idea in mind: to reduce costs while ensuring compliance.
The poor performance of the industry forced manufacturers to embrace change and adhere to a new business approach. Their bottom lines shouldn’t suffer, so they had to rely on pharmaceutical consultants to help them. Huge efforts were made to increase the efficiency of operational and manufacturing processes, and little by little, they improved their overall efficiency, reducing waste and controlling inventory. The concepts of Lean Manufacturing and Six Sigma approaches were critical, and soon the support of the FDA and other regulatory institutions was evident, as the new approaches sought to reduce risk by assessing quality from the beginning, and not relying on end-process testing. The FDA, did its part when it launched its own Process Analytical Technology (PAT) initiative, focusing on quality improvements in the manufacturing process through lean analysis of variable process attributes on product quality . The whole industry started changing, and the process has been painful, but very productive.
Under the new approach, the pharmaceutical industry had to focus on change at three levels:
Operating systems: Material and information flow analysis are vital for designing lean production, lean systems, create tactical implementation plans and develop work charts and instructions. Understanding demand levels is a must.
Management systems: Defining management tools required by the company (e.g. IT systems, communication tools, etc.), assessing management and changes that support Lean concepts, measuring success through key performance indicators (KPIs) at different levels of production and creating a problem resolution system to drive and institutionalize change are the steps to take here.
Transformation of mindsets/behaviors: The most challenging step. Defining and communicating a consistent mission, vision, and value system across the organization are the key issues. Focus on the customer. Provision of training opportunities at different points in the process, in order to build stronger organizational buy-in and competence (executives and staff)
Process and workflow automation have been vital to improve quality as well. Integrated IT infrastructures make pharmaceutical manufacturers rely and depend less on manual checks, for presenting greater risk and variability. Automated checks are far more precise and can be easily audited by the FDA and other regulatory bodies. Data can be collected from every part of the supply chain and manufacturing process, manufacturers now understand how various process adjustments can affect directly the technical attributes of the material.
The pharmaceutical industry is back. Little by little, quality and efficiency have been improved, ensuring consumers’ welfare and loyalty as well. At the beginning, pharmaceutical manufacturers rejected change because of the costs, but in the end they were able to understand that change would be less costly than losing their market share for good. The change required an important investment and a significant amount of patience, but the results are already evident. The reject percentage is decreasing, costs have been reduced, less waste is produced, and consumers have started feeling safer. For the pharmaceutical industry this was a crisis hard to detect, a little harder to fight, but in the end, it only made it stronger.
