This guideline, issued under 21 CFR 10.90, states principles and practices of general applicability that are not legal requirements but are acceptable to the Food and Drug Administration (FDA). A person may rely upon it with assurance of its acceptability to FDA or may follow different procedures. Any person who chooses different procedures may, but is not required to, discuss the matter in advance with FDA to preclude expending money and effort on activity that FDA may later determine is unacceptable.

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Computerized Systems in Drug Establishments

Computers are being used in increasing numbers in the pharmaceutical industry. As microprocessors become more powerful, reliable, and less expensive we can expect the proliferation of this technology, with increasing use by even very small pharmaceutical establishments. Computer systems are used in a wide variety of ways in a pharmaceutical establishment, such as, maintenance of quarantine systems for drug components, control of significant steps in manufacturing the dosage form, control of laboratory functions, management of warehousing and distribution activities. Computer systems may control one or more of these phases, either singly or as part of a highly automated integrated complex. The purpose of this guide is to provide the field investigator with a framework upon which to build an inspection of drug establishments which utilize computer systems. This document is not intended to spell out how to conduct a CGMP drug inspection or set forth reporting requirements, but rather what aspects of computerized systems to address during such inspections and suggestions on how to address the systems.

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