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Lean Pharma

The continuous pricing pressure on drugs means that the pharmaceutical industry does not only need to deliver a patient-safe quality product, they must also produce it at the lowest possible cost. Therefore most pharmaceutical companies have (extensive) improvement programs deployed in their manufacturing area. Lean concepts such as TPM, SMED, 5S and visual management are in place to ensure a drug can be formulated, filled or packed within the smallest timeframe and at the lowest cost possible.

  • Jan Van Loon
  • 12 januari 2017

But how many improvement projects are conducted on production-supporting processes? How lean or defect-proof are they? Many of these processes are established to ensure product quality and although they might, by definition, not directly add value to the product, they may add a significant cost if not executed in an efficient and effective manner.

An example of these production supporting processes is the deviation handling process. Unfortunately not every manufacturing (or laboratory) activity goes according to plan and deviations from standardized procedures occur. These deviations must be documented and their impact on quality and compliance must be assessed. The cause should be determined and corrective and preventive actions must be defined and approved by the responsible parties. As the process lies on the critical path to product release, and deviations with quality impact might be subject to regulatory notification timelines, it’s essential that this process runs efficiently, without compromising on the quality of the outcome. Bearing in mind that the most ‘lean’ way of deviation handling is to have no deviations at all, it is of major importance to identify the true root cause of a deviation and prevent it from reoccurring.

But it’s not only the deviation handling process that impacts the product release. Laboratory testing and batch record review increase lead times as well. While pharmaceutical laboratories often have continuous improvement initiatives such as Lean Laboratory, it is noticed that they are hard to maintain when the workload is rising. The batch record review process is a very administrative and time-consuming process, and often forgotten when it comes to continuous improvement efforts. What must be reviewed, when and by whom? Often parameters are systematically reviewed due to a one-time deviation, but this is hardly ever the best solution. The more different products a company has, the more challenging it becomes to define a standard way of working and implement a lean approach.

Today, most continuous improvement programs focus on manufacturing processes. However, once manufactured, the product’s critical path to release is determined by laboratory and quality assurance processes. As a result, today’s challenge is to make these processes time- and cost-efficient so their impact on the supply chain stays as low as possible. Therefore they should be part of an improvement program that emphasizes on waste elimination (to ensure an effective process), standard work (to ensure a repetitive process) and visual management (to ensure a controlled process). Continuous improvement can be enforced by assigning resources that become available by conducting improvement projects to the further analysis and improvement of the standard.

Do you need some advice on how to tackle these challenges? Ordina’s Quality and Compliance team has the knowledge and experience to assist you in doing this.