Manufacturers offered helping hand with EU approval

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

The process of manufacturing concrete masonry units begins by mixing stiff concrete composed of Portland cement, aggregates, and water. This mixture is then poured into metal molds. To ensure the concrete settles uniformly and to avoid separation of its components, the mixture in the molds is subjected to vibration. Shortly after, the still-wet blocks are removed from the molds and placed on racks.
These wet blocks are then transported for curing, which can occur in one of two environments: a...

Steel manufacturing is a multi-stage process that begins by smelting iron ore into cast iron in a blast furnace. This initial stage involves layering iron ore with coke, a type of fuel, and crushed limestone within the furnace. The coke is ignited with a high volume of air, leading to the creation of carbon monoxide, which acts to reduce the iron ore to pure iron.
During this smelting process, limestone plays a crucial role by forming slag. Slag captures impurities within the molten iron, such...