The production ramp-up is the critical phase between the pilot and mass production. A small error can cause significant losses. Therefore, it is essential to ensure that all systems, processes, and equipment are technically validated before starting scale production. A safe ramp-up starts with a well-structured technical checklist. And ends
The validation of equipment, systems, and processes is essential to ensure that they function correctly, safely, and according to specifications. The IQ/OQ/PQ model is an established methodology in the pharmaceutical, cosmetic, food, medical, and electronic industries, especially those following standards such as GMP, ISO 13485, FDA 21 CFR Part 11,
Industrialization Engineering is the area responsible for transforming a developed product into something ready to be produced on a scale, with quality, repeatability, and efficiency. It acts as a bridge between R&D, production, quality, purchasing, and testing, ensuring that the product is industrialized in a feasible, testable, and documented manner,