Many developments in the industry indicate that this is the proper course:
- Products are becoming more complex. Supply chains that remain at a low process sigma and low process capability would result
in high yield losses, unreliable supply, and increased likelihood that out-of-specification product reaches the patient. Product
complexity comes in the form of biologic drugs, drug–device combinations, and time-released products.
- FDA is encouraging improved process control and acknowledging that some of its regulations have been obstacles to this goal.
The agency is encouraging manufacturers to adopt PAT and decreasing approval times for new products filed with this type of
- Mapping the human genome means that the ability to determine drug efficacy based upon genetic makeup will decrease the number
of blockbuster drugs. Industry supply chains will need to make more products at lower volumes. Process capabilities must improve
for companies to efficiently produce this mix of products.
- Because products' complexity is increasing and their side effects are growing more acute, the industry and FDA are becoming
increasingly concerned about spikes in dosing. These concerns are inspiring the development of active delivery mechanisms
that increase the demands on the supply chain's process capability.
Improving process capability significantly can be a daunting task, but current technologies make this project more feasible
and faster to complete. In the past, regulators' conservative approach discouraged innovation, but today they are willing
to assist and encourage transformation. This support is based on the belief that increased scientific understanding and applied
technologies reduce variation and risk.
EPCAM integrates information
EPCAM integrates information through a combination of open applications, integration software, and adaptive process-control
software. Integrated information enables the macro management process to improve manufacturing processes. The following results
occur when EPCAM is fully implemented in both manufacturing and product-development environments:
- CpK improves from the typical level of 0.7–1 to > 2
- Process sigma improves from roughly 2 to about 4.5
- Costs of compliance and nonconformances decrease sharply, and the possibility of recalls is greatly minimized
- The reliability and speed of new product launches are greatly improved
- Manufacturing throughput is increased.
Many EPCAM software components support open standards and are not proprietary. EPCAM works with most installations of commercially
available software (MES, ERP, and LIMS). Two proprietary applications, APC and FDC, will be discussed in more detail. Companies
want to achieve the level of quality that EPCAM process control failitates, but they are uncertain about how to make the transition
from the current environment to the targeted EPCAM end state. To make this change, the authors have developed a phased approach
that progresses through five logical levels of control (see Table I).
Table I: Process-control hierarchy.
The achievement of each level improves quality and control and leads to business benefits such as greater yields and better
products. In addition, organizational capability (e.g., process skills, experimentation skills, the number of experienced
people) grows with the attainment of each level. When companies reach levels 4 and 5, their organizational capability and
process-control skills must keep pace with their technological advancement. It is absolutely critical to build the organization's
process-control expertise, discipline, and the culture of control in both the manufacturing, product-development, and information-technology
organizations as progress is made.
Table II: Transformation demands from the current state to the desired state using EPCAM.