GxP/GMP and its Consequences for Documentation and Information Technology Systems

Abstract

Eleonora Babayants

Documentation is a critical tool for ensuring GxP/GMP compliance. In the regulated environment which must be GxP/ GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure. In this article, the connection between GxP/GMP and document control is discussed. Details of document control procedures and the role of Quality Assurance in the documentation systems are described. GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/ GMP requirements are reviewed. There is also a review of change control procedure and how it should be used in GxP/GMP environment.

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