Even the simplest form of pharmaceutical manufacturing process can involve a range of process steps before the product is packaged and shipped to the consumer.These may include:
Poor environmental control, particularly in terms of air humidity can directly affect the pharmaceutical production line in a number of ways. Levels of humidity below 45%RH will allow electrostatic charges to build up in machinery and materials.
There are many factors to be considered in the quest for drug quality assurance.These include environmental moisture, stability and packaging solutions.If all of these aspects are addressed throughout the manufacturing and storage processes, the product can be isolated and protected from all possible threats to quality and efficacy.
Validation is establishing documented evidence which provides a high degree of assurances that a specific process or equipment will consistently produce a product or result meeting its predetermined specifications and quality attributes.This article focuses on the process of dry mixing of powders, as one of the steps in producing tablets.Validation can therefore be applied to the dry mixing process itself, as well as the overall manufacture of tablets.