Essential elements of quality control.

Abstract

The components of quality control in the pharmaceutical industry are discussed as they apply to hospital pharmacy admixture services. The pharmaceutical industry complies with the FDA's Current Good Manufacturing Practices, which require manufacturers to have written procedures for ensuring sterility and nonpyrogenicity of injectable products. Because FDA specifies only what outcome measures must be assessed (rather than specific means of assessment), pharmaceutical companies have developed a multiplicity of quality-control systems. However, each system consists of a master formula (quantitative listing of all ingredients), master manufacturing instructions (the recipe for each product), master packaging instructions, and batch records. Documents used by quality control personnel include the specifications (identification, tests, and limits for products), test methods, and sampling procedures. Hospitals should have similar quality-control programs. These programs should systematically prevent or identify and correct deficiencies, measure overall quality, and provide information for managers. Hospital pharmacists whose departments do not have comprehensive programs should consult colleagues who have developed such procedures. Techniques used in industry should be applied when possible. To protect the integrity of manufacturers' drug products during compounding in hospitals, every hospital admixture service must have its own quality-control system.