User Requirement Specifications consist of Design Specifications and Functional Specifications. Design Specifications provide explicit information about the design requirements for equipment e.g. the dimensions, material of construction, layout, etc. Functional Specification denotes how each feature of the equipment/system must function.
GOST Company Introduce all wide types of testing as next:
Thermometers with Dry Block Calibrators.
Ovens & Environmental Chambers.
Thermocouples and validator
Data Loggers low and High Temperature Range
Vacuum Pressure Gauges.
HVAC system Qualification
HVAC System Qualification PQ for Clean Room (at Rest and at Operation)
Temperature and humidity test
Differential Pressure testing ,adjusting and Balancing
Particle Count Test
Air Pattern test
Air Flow Quantity CFM
DOP test class C,B,A
Differential Pressure for each Section (fan and Filters)
Air Flow Quantity CFM
Fan Speed- RPM
Motor Speed- rpm
DOP test for HEPA filters
LAF Qualification IQ, OQ & PQ
Factory Lay out and HVAC AutoCAD Drawings ( Personal Flow – Material Flow – Class Classification – Temp& humidity Distribution – Waste Flow – differential Pressure Distribution – Factory Room Coding – AHU Serving Area - ……) with AutoCAD form.
Factory Acceptance Test (FAT)
Checks for completeness of installation.
Verification of URS with the actual.
Proof of functionality, by either a conventional function test or by simulation.
Verification of documents (availability and quality).
Site Acceptance Test (SAT)
Verification of equipment design
Specifications of received equipment at the site of User by received documents/drawings from Manufacturer / vendor
Installation qualification test consist of checking of:
Presence of all components of the equipment ,Damages to the component ,Design features of all critical component e.g. dimension, make, model, Material of Construction etc. ,List of Instruments requiring qualification, Utility connection against applicable specification, Availability of required documents , Verification of drawings, Assembly of components against the manufacturer’s recommendation.
OQ specifically tests each function of the system e.g., unit operational functions, specific equipment functional testing, etc. This is to ensure that the intended tasks will be performed when the system is adjusted and operated throughout the recommended operating ranges.
The OQ execution process provides an assessment of the system operation.
The OQ phase includes calibration/testing of the instruments.
For instruments such as dial type gauges, load cells, etc., where there is possibility of malfunctioning due to improper installation/transportation calibrated at site during OQ.
During OQ, if any calibration activities are undertaken by an external agency, the calibration reports of such activity reviewed by site representative for compliance to laid down specifications.
The PQ integrates procedures, personnel, systems, and materials to verify that the pharmaceutical grade use, environment, equipment, or support system produces the required to be output. This output may be the product or product contact use (cleanse compressed air, purified water, etc.) or environment (HVAC system). Acceptance criteria should be clearly indicated in the PQ document.
The PQ is the final stage of qualification, which demonstrates how equipment/system will perform under simulated or actual production or operating conditions.
This series of tests is designed to demonstrate that the equipment/system is capable of consistently operating and manufacturing product of specified quality in the worst case. This phase can only be undertaken once the operating parameters have been defined and approved.
Re-Qualification is an activity involving complete or portions of ‘elements’ of qualification activities, like IQ, OQ and PQ.
Re-Qualification carried out for one or more of the following reasons: To address deficiencies observed in an executed qualification, To qualify changes done in the equipment or a process involving the equipment, Failure, CAPA, Findings/Recommendations from Inspections/Audits/ PQR, etc. Inputs from Preventive Maintenance/Calibration Program, Equipment Up-gradation.
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