The intent is to determine the need for action to ensure and document that the system is maintained in a validated state”Ĭhange control is a regulatory requirement by various regulatory bodies, and the change control process gets reviewed during the inspections. “A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The EU GMP is divided into various annexes, each annex describing different pharmaceutical industry processes.Īnnex 15 describes the principles of Qualification and Validation for facilities, equipment, utilities, and processes, including Change Control.Īccording to Annex 15 of EU GMP, change control is defined as: Definition of Change Control by Annex 15 of EU GMPĮU GMP is a European body that specifies principles and regulations for ensuring standardization in medicines and pharmaceutical products in European Union. It ensures that the change does not affect the output’s intent and fulfills all the quality principles associated with that specific product or process. What Is Change Control in Pharmaceutical Industry?Ĭhange control in the pharmaceutical industry is used to modify any process or pharmaceutical SOP. Frequently Asked Questions About Change Controls.
#Dossier meaning in pharmaceutical industry software
What Are the Different Types of Change?.What Is Change Control in Pharmaceutical Industry?.Finally, we will cover the types of change and how software can help implement a successful change control process. In this article, we will look at the definition of a change control process, its types, and the steps of implementing a successful change control process.
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