Acceptance Sampling Plans by Attributes

As the field of quality control enters the next millennium, many pharmaceutical and biotechnology companies have striven to achieve quality in the drug and biologic products they manufacture. This is due in part to increasing public demand for products to be free of defects, as well as the 1987 publication by the international organization for standardization (commonly referred to as ISO) of the ISO 9000 series of standards for quality management and quality assurance. The ISO 9000 standards provide guidance for manufacturers to implement effective quality systems. They are also widely used by customers as a yardstick to measure the adequacy of the producer’s quality system. Manufacturers are motivated to be certified by registrars accredited by the ISO so as to enhance potential customer confidence in the quality of their products. An excellent review of ISO 9000 was given by Rabbitt and Bergh (1997). In 1994, the United States Congress passed the current Good Manufacturing Practice (cGMP) Act initiated by the Food and Drug Administration (1995). Since then, lawsuits have been filed by the FDA against a few pharmaceutical companies for failing to appropriately implement cGMP guidelines in their product release. The legal actions added a new tempo to the improvement of producers’ quality systems. As one of the key elements in the ISO 9000 standards and an integral part of the cGMP, acceptance sampling inspection before the distribution of a product lot is mandated by law.