EPCAM: A Strategy to Enable Manufacturing-Process Control Transformation - Pharmaceutical Technology

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EPCAM: A Strategy to Enable Manufacturing-Process Control Transformation
Enterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.

Pharmaceutical Technology

Thus, EPCAM allows process control to be executed across the enterprise in an efficient, reliable, and effective manner.

EPCAM can be achieved in a controlled, phased approach. There are five logical levels or phases in moving from the typical environment to the EPCAM end state.

The fifth and lowest level is the automation of the batch record (i.e., electronic batch records). The fourth level is MES. The third level is point-to-point process control using PAT. The second level is adaptive process control (APC), which links process control across multiple operations. The first and highest level is FDC, which enables control of processes and the environment. These levels will be explained in more detail in the "EPCAM solution and value" section. Achieving EPCAM can seem like a daunting journey, but the process can be completed in steps, building the organizational capability and trust required along the way.

The typical manufacturing environment in a life-sciences or healthcare company

Figure 1 depicts the current and desired states of most manufacturers in the life-science and healthcare industries.

Traditionally, supply chains in the pharmaceutical industry have not been expected to be efficient. They have merely been expected not to cause problems. In general, the industry's margins have been sufficiently high, and lost sales received more attention than inventory control. Because the industry is regulated, making a significant process change often requires revalidation. Compliance and responding to nonconformances have always been the first priorities from a process perspective.

As a result, process quality today in healthcare is about 2 sigma, and process capability is around 1. Many processes are less than 1 sigma, and the cost to serve is relatively high. EPCAM provides the opportunity to improve process quality, process capability, and cost to serve. EPCAM goals for the pharmaceutical industry are levels of at least 4 sigma for the manufacturing processes and process-capability (CpK) of critical operations of 2.5 sigma.

Figure 1: The business case for enterprise process control and management (EPCAM). (AUTHORS)
It would be disastrous for product of 2-sigma quality to be released to patients. Recalls would be extensive, adverse events would abound, the industry would lose credibility, and patients would be at increased risk. For this reason, the industry has instituted robust inspection processes that raise product quality to approximately 6 sigma (see Figure 1). Most companies continue to invest in inspection to improve quality even more (see the short red arrow in Figure 1).

The authors believe, however, that the right course is to invest in improving process sigma and process capability (see the long red arrow in Figure 1) while keeping the inspection capability constant. Thus, product quality for the patient would increase to 7 sigma and attain the benefits of lowered cost and reliable supply. The volume under the curve in Figure 1 can be used as a relative indicator of the cost of quality.


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