Guidelines for Developing Calibration Parameters in the Pharmaceutical Industries

摘要

In the late 1970's the Food and Drug Administration (FDA) developed the Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) guidelines for the pharmaceutical industries. A section of the GMP/GLP guidelines requires calibration of the instrumentation within the laboratories. To meet this calibration compliance issue some of the pharmaceuticals have established in-house metrology programs. Developing an in-house metrology program, due to the multitude of metrology components, can engender a series of involved and often confusing activities. Many of the pharmaceuticals are using personnel, primarily trained in other fields who are not familiar with Metrology (e.g., quality control personnel, process engineers, and/or technicians), to coordinate such activities. Coordinators of Metrology functions need to know the methods, equipment, and the current technology, to efficiently establish a calibration procedure. The purpose of this paper is to establish guidelines for pharmaceuticals to aid in the development of calibration procedures, including examples of some typical problems that can be expected as these procedures are developed. The task of deciding which instruments are critical, and how to gather the information to develop calibration procedures for these instruments is reviewed in this paper.