FREQUENCY : QUARTERLY
PUBLISHER : ANANDI HEALCARE LLP,WASHIM-444505
CHIEF EDITOR : Dr. Prashant Sakharkar
COPYRIGHT : INTERNATIONAL JOURNAL OF PHARMACY AND HERBAL TECHNOLOGY
STARTING YEAR : 2023
SUBJECT : MEDICAL SCIENCES
LANGUAGE : ENGLISH
PUBLICATION FORMAT : ONLINE
PHONE NO : +91 9172954046
EMAIL ID : editorijpht@gmail.com
WEBSITE : www.ijprdjournal.com
ADDRESS : Near Kaleshwwar Mandir Shukrawar peth, Washim-444505 Maharashtra
Author Name: Sayali S. Ghule, * Yuvraj N. Arjun, Sanjay K. Bais
Email: ghulesayali1112@gmail.com
College: Fabtech College of Pharmacy, Sangola, Maharashtra 2597-2608
The procedure was registration of determining or verifying which services, tools, support Machines are capable of operating within parameters for the purposes for which they were designed. It is a component of validation. A crucial component of the pharmaceutical quality system is equipment qualification. Regulatory bodies have been emphasising equipment qualification more recently. The process of certifying equipment begins with its design, which is guided by the functional and user requirements specified. In regulated industries, equipment qualification is a crucial procedure, especially in the biotechnology, medical device, and pharmaceutical sectors. It protects product quality and patient safety by making sure that equipment works well given its stated objective, runs dependably, satisfies predetermined requirements. Installation Qualification (IQ), which confirms proper installation and operational readiness, Operational Qualification (OQ), which evaluates the equipments performance across predetermined operational parameters; and Performance Qualification (PQ), which confirms the equipments efficacy under real-world production conditions, are the three main stages of the qualification process. Organizations can improve regulatory compliance and reduce the risk of equipment failures by adopting a systematic strategy that includes risk management, documented proof, and specified acceptance criteria. This article provides a detailed explanation of the equipment certification processes that are supplied for the aqueous granulated producing activity. Its activity of indicating all anticipated usability essential function of various infrastructure essential machinery is known as qualification, and it is a perfect first step in the equipment validation process.
Qualification, Equipment