A "deviation" in manufacturing is when manufacturing steps are changed in some way from the set guidelines. Production guidelines are very detailed based on supply contract specifications, product ...

Learn about virtual control and the key indicators that signal whether your manufacturing facility is truly prepared for ...

Medical device manufacturers are adopting integrated quality management systems that extend past compliance to drive cost ...

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...

ocated 90 minutes west of Tokyo in the shadow of Mount Fuji, Oshino, Japan, is home to 9,000 people—which means that in any given year, the robots produced at the town’s FANUC plant outnumber humans ...

At its core business process management is the administrative activities aimed at (1) defining a process, (2) establishing responsibilities, (3) evaluating process performance and (4) identifying ...

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

Whether you own a small manufacturing company or you have a company that relies on manufacturers to make your products, it's important to understand manufacturing objectives and goals. The truth is ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...

Single die packages and products have been the norm for decades. Moreover, so has multi-chip modules (MCMs) or system in package (SiP) for quite some time. Understandably, with ASICs and SoCs becoming ...