Process capability increases to more than 2.0 with this type of control. Process capability can rise to the point where nonconformances become an annual event rather than a daily occurrence. This control is called adaptive because process and product data are fed forward to the process-control management system. APC instructs controllers so that the current processing step is adapted according to the known condition of the materials. This flexibility further reduces variability within specifications and increases process capability.

In addition to quality and compliance, benefits include reduced product variability, which ensures safety and efficacy in drugs and devices. FDA is increasingly concerned about the need for constant active dosing levels in patients. This level of process control will reduce product variability to help ensure constant dosing.

Level 5, FDC, adds the remaining elements to the process-management picture. It brings control over the environment. It measures and controls elements that are largely constant but drift over time or vary because of events such as normal wear, abnormal wear, maintenance, or software upgrades. The following situations describe examples of what FDC controls:

The residual gas analyzer that provides environmental control could have detected the change in air composition before the operation started a second sterilization batch. In this case, only one batch would have been affected. FDC's classification capability would also have instructed the operator or mechanics where to look for the problem.

Example II. A manufacturer lost several batches of a sold-out product because of low active-release rates. During manufacturing, the product was a capsule with a hole that allowed the active to enter the patient's body over a period of time. The capsule was held in place by a spring-loaded clamp and laser drilled. During routine maintenance, the standard springs were not available, so stronger springs were used. The stronger springs increased the clamping pressure and forced the active out of the capsule during the drilling operation. This deviation caused the low release rates. FDC could have detected the increased clamping pressure and alerted the operator and the mechanic of the problem before the first batch was run, thereby saving several batches of the sold-out product.

FDC detects machine failure, machine drift, and environmental changes long before procedures or routine checks would identify such conditions. FDC detects failures through monitoring machine parameters and analyzing them in relation to each other. For example, suppose a machine running in a partial-vacuum condition demonstrates pressure within specification, but the vacuum pump is pulling more electrical current than it normally does. Suppose the pressure varies within the chamber more than normal. FDC would detect this anomaly and send a message to the operator to check the seal or the pressure plate. This action would occur well before an out-of-specification situation could occur.

FDC enables excellent process control and anticipates problems before they occur. FDC allows the manufacturer to achieve the perfect or "golden model," the conditions that produce the product with the right attributes all the time with minimal variation. The conditions include the processing parameters such as temperature, pH, conductivity, pressures, speeds, and product attributes from the previous operation. The conditions also include environmental factors such as the manufacturing air and machine statistics such amp usage, pressures, and speeds. The process, environmental, and machine conditions are recordeded to achieve the golden model. The golden model can then be attained every day with FDC and APC.