Ad copy

An Equipment Validation Protocol (also known as an equipment qualification protocol) is a written plan that outlines how to test and verify equipment, piping, instruments and utilities in a critical system to make sure it works properly and consistently according to its intended use. The protocol is used in regulated industries such as pharmaceutical manufacturing and typically includes these processes: Installation Qualification (IQ): Verifies that the equipment is installed correctly, according to manufacturer’s specifications and site requirements. Operational Qualification (OQ): Tests the equipment to ensure it operates as intended within established parameters. Performance Qualification (PQ): Confirms that the equipment performs under load according to the design specifications. Each step (IQ, OQ, PQ) builds on the previous one, progressively confirming the equipment’s reliability and functionality. These steps are collated in the equipment validation protocol which: - lists all the equipment, piping, instruments and utilities that need to be tested - defines the test scripts that must be followed to make sure the equipment operates correctly - outlines how to perform the tests - specifies who will conduct them - records whether the equipment, along with its piping and instruments, passes or fails the tests - details the required proof and the expected outcomes - describes the steps to take if the actual outcomes deviate from expectations Each critical system has its own protocol. The objective is to create documented evidence to prove “fitness for use ” of an equipment system. It makes sure that a facility and the equipment in it, function as required so that it can be approved by the regulatory agencies that have jurisdiction over that facility. Note: Equipment Validation and Equipment Qualification are often used interchangeably. However, some industry professionals argue that ‘Equipment Qualification’ is more precise, as you ‘Qualify’ equipment, piping, instruments, and utilities. In contrast, ‘Validation’ is typically reserved for processes, procedures, and methods. For the purposes of this guide, we will use both terms.” Read more at https://www.getreskilled.com/validation/validation-protocol/