Material pharmaceutical drug formulations quality

Peroxidation and free-radical formation should be considered as important aspects of pharmaceutical stability and quality of parenteral nutriton and intravenous drugs. Peroxidation and free-radical formation depend on environmental factors, such as storage conditions and container material, but are also influenced by formulation components or additives such as tocopherols and metabisulfite. Since the generation of these harmful species occurs generally at the time of use, manufacturing quality controls fail in demonstrating their existence. 

The pharmaceutical industry manufactures dosage forms in large-scale formulations. The decision to scale up is based on the economics of the production process related to costs of materials, personnel, equipment, and control [2], To reduce costs of wastes and to obtain high-quality and efficacious drug products, the strategic plan to be applied during the process has to be developed carefully. In fact, the variables that affect product quality are identified and understood in the process instead of tested into the final product [3],... 

In the pharmaceutical industry, while drug research or R D is formulating the active product, basic packaging presentations will be vetted as primary containers (i.e. for material stability and compatibility). However, once the drug moves into the production development interface, its total packaging design and application for production, distribution, market (and supplier) necessitates close formal liaison between the writers of the component specification and the quality inspection procedure. 

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