Component delivery, quality control

The key parameter for any drug product is its efficacy as demonstrated in controlled clinical trials. The time and expense associated with such trials make them unsuitable as routine quality control methods. Therefore, in vitro surrogate tests are often used to assure that product quality and performance are maintained over time and in the presence of change. A variety of physical and chemical tests commonly performed on semisolid products and their components (e.g., solubility, particle size and crystalline form of the active component, viscosity, and homogeneity of the product) have historically provided reasonable evidence of consistent performance. More recently, in vitro release testing has shown promise as a means to comprehensively assure consistent delivery of the active component(s) from semisolid products. 

Evaluation of pharmaceutical systems is consensually recognized as an important component of their development and quality control. Although evaluation of general features (e.g., drug content) is also required for vaginal formulations, this section focuses only upon some of the most important parameters that are intimately related to drug delivery systems specifically designed to be administered by this route. 

The quality control procedure can be viewed as the framework built around the component specification which will translate the development laboratory target (ideal) into the mass production consumables (practical). The quality procedure is devised to achieve consistency of component deliveries by realistically ... 

As part of the quality control process, all components delivered to site must be accurately identified. The delivery ticket should contain as much detail as possible of the manufacture of the unit and its subsequent curing and storage. Some checks will be required on site, as detailed in 7.2.2, particularly in the case of damage during transit, but in general the components should be delivered with certificates confirming that they conform to the specification. 

We present EC s history according to these three facets with the aim of identifying components that are still missing for fully integrated electronic commerce activities, in particular those that refer to the coordination and control of activities for manufacturing activities among partners for quality product delivery and customer satisfaction. 

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