User Requirement Specificatio (URS): Define the intended use of the instrument. List performance requirements, such as accuracy, precision, and operational range. Include compliance needs with GMP, GDP, or other regulatory guidelines. Design Qualification (DQ): Document that the design of the instrument ...

by Andrea Vignoni, Pharma CQV Expert & Senior Consultant Validation is an integral part of the pharmaceutical industry involving two key phases that work in tandem to ensure the highest quality and compliance standards. These phases, commissioning and qualification, are carefully executed to guarantee ...

Design qualification is defined as a verification process of design to meet specific requirements related to quality of pharmaceuticals and manufacturing practices. However, design qualification procedures in pharmaceuticals are one of the reasons why some products do not make it onto drugstore shelves. It ...

Performance Qualification (PQ) performed after successful completion of the Installation and Operational Qualifications execution, for those critical systems or processes requiring PQ that should be validated to provide assurance of process repeatability. One of the purposes of PQ is to test the ability ...

Operational Qualification (OQ) has to be performed after satisfactory completion of the system/equipment Installation Qualification execution. The OQ describes the operational tests, measurements, and control tolerances of key parameters that are critical for the proper operation of the system. Test ...

The data collected during the Installation Qualification can be packaged and summarized either individually or as part of an IQ/OQ/PQ package for presentation, review, and approval. The Installation Qualification Protocol provides a systematic method to check the system/equipment static attributes ...

To lay down the procedure for facility qualification Responsibility: > Engineering Manager or his/her designee will be responsible for initiating facility qualification. > Validation manager will be responsible for checking sufficiency in protocols and reports and requirement of facility qualification ...

Qualification: Qualification is objective evidence that equipment or system and its ancillary systems are correctly installed, work as expected, and fit for the intended use. -Crux of all definitions Validation: Validation is the collection and assessment of data from process design to commercial phase, ...

Objective: This Standard Operating Procedure is to describe that equipment cannot randomly selected and directly put into use. It is essential to ensure suitability for performing Equipment Qualification (s) against requirement and performance capability over a period of use. Hence it is to be qualified ...

Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose. Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified & comply with the approved design ...