Installation Qualification (IQ) is ascertaining that all the important aspects of process equipment together with ancillary system installation follow the approved specification of a manufacturer and what the supplier recommends. An equipment has to be installed by trained personnel according to the drawings and specifications provided. An approved protocol designed by an engineering department is used for performing an IQ. All procedures to do with maintenance, cleaning and calibration are drawn at the installation stage.
Before an engineer can install pharmaceutical equipment, he/she has to make sure that all the components that had been ordered are delivered. Design specifications indicating components of pharmaceutical equipment are needed before acquiring equipment. This includes the construction materials and power specifications. Prior to the delivery of equipment, it is good to order for manufacturer's manuals. Safety precautions together with hazard precautions need to be reviewed. Program functions have to be configured and installed and leak tests may also be conducted where needed. All system parts, controls, and services should be verified. National and international standards must be used when calibrating the measurements and controls.
The equipment description and identification section of the installation qualification protocol should provide the name and address of the manufacturer of the supplying company. The serial number of the pharmaceutical equipment together with the equipment model should also be noted as part of the installation qualification procedure. Other details to be included in the description and identification section of the pharmaceutical equipment include the dates when the equipment was purchased, received, and installed, the equipment location and the purchase order number.
In the installation qualification procedure, there should also be specifications of the major components of the pharmaceutical equipment. Specifications may be checked by conducting calculations, measurements, nameplate details, physical inspections and test certificates on the manual.
Another area of the installation qualification protocol of a pharmaceutical equipment is the equipment master files. This section shall contain reference material like manuals for instruction and maintenance. This section of the installation qualification protocol should also have a list of drawings. Spares and test certificates should also be added in this section. The safety features and alarms section of the installation qualification protocol provides alarms and safety interlocks list required for qualification.
In the standard operating procedures also known as SOPs and the preventive maintenance procedures section, the all the standard operating procedures and preventive maintenance procedures for the pharmaceutical equipment are provided.
Another section of the installation qualification protocol include the installation verification assists with the verification of parts and instruments of the whole equipment. There is also a section for that assists with the identification of the material of construction of the pharmaceutical equipment and all its parts.
The last section of the installation qualification protocol is the acceptance criteria which verify that the parameters of the equipment at installation match the acceptance criteria.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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