Successfully manufacturing a drug product requires people, proper equipment, and materials. It’s the classic three-legged stool analogy. Even with well-trained staff and high-quality materials, if the equipment does not function as expected, or is not reliable, the final product can never be cost-effectively produced. Product quality will likely be compromised as well.
So what is equipment reliability? Simply put, it is a function of the equipment’s ability to operate as desired over time. Therefore, improving the reliability of equipment has a direct impact on product quality and production efficiency. The impact is often immediate and extremely costly to the enterprise. Without reliable equipment, there will be no operations and without operations, there will be no commerce and therefore, no enterprise. By necessity, equipment management is fundamental to the modern manufacture of virtually everything and especially critical to the production of today’s pharmaceuticals. Because manufacturing requires the precise integration of equipment, each step must be ready to hold up its end of the bargain in the process. Demonstrating the continuity and uniformity of the production process is mainly dependent on the stable operation of equipment capable of functioning in a desired and steady state.
