ABSTRACT
Pharmaceutical manufacturers commonly use audits as an effective mechanism to verify compliance with the good manufacturing practices regulations (GMPs). GMP audit programs are designed with two important goals in mind. First, audits are intended to verify that manufacturing and control systems are operating under a state of control. Secondly, audits can detect potential problems to permit timely correction (preventing release of adulterated products to the marketplace). Audits can be used by management to establish, with a high degree of confidence, that systems can be expected to remain under an adequate level of control. There are many different approaches, styles, or formats that can be used. Each firm must design and implement an audit program that will meet its own needs and goals. There are considerable differences between parenteral drug manufacturers in the breadth and depth of their audits. Choosing ways to optimize efficiency and effectiveness is an especially challenging task, because there are so many factors to consider.
