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  • General Organization for Surveillance and Testing

    Quality Is Our Sustainable Asset

    GOST Egypt

    Qualification Process

    Qualification Process

    Qualification Process

    General Organization For Surveillance & Testing

    Need of Qualification

    • To manufactured a quality product
    • Proof “suitability for intended use”
    • Regulatory requirements
    • Cost effective

    Qualification Startup

    To initiate the qualification of pharmaceutical equipment a frame work before startup is required:

    • Defining User Requirements (URS) Defining Functional Requirements for given User requirements (FRS)
    • Defining Design based on URS & FRS (DQ)
    • Factory Acceptance Test at the site of manufacturer (FAT)
    • Site Acceptance Test at the site of user (SAT)
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)

    Qualification service

    • HVAC System Qualification
    • HVAC Testing, Adjusting and Balancing
    • Thermal Mapping
    • Production Machine Qualification ( IQ,OQ,PQ)
    • Facility Qualification.
    • Clean Room Qualification.

    Facility Qualification Scope includes: Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ)

    User Requirement Specification

    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:

    1. Temperature
    • Thermometers with Dry Block Calibrators.
    • Ovens & Environmental Chambers.
    • Temperature Indicators.
    • Temperature Controller.
    • Thermocouples and validator
    • Simulators.
    • Transmitters.
    • Thermometers.
    • Data Loggers low and High Temperature Range
    1. Pressure
    • Pressure Gauges.
    • Pressure Transducers.
    • Pressure Switches.
    • Pressure Calibrators.
    • Vacuum Pressure Gauges.
    • Vacuum Transducers.
    • Manometers.
    • Data Loggers.
    • Vacuum devices.
    1. Humidity
    • Data Loggers
    • Hygrometers
    1. Electronic
    • Multimeters
    • Process Calibrators
    1. Mechanical Dimension
    • Tachometers
    • Torque Wrenches
    • Micrometers
    • Calipers
    • Height Gauges
    • Dial Gauges

    HVAC system Qualification

    1. 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
    • Recovery Test
    • Air Pattern test
    • Air Velocity
    • Air Flow Quantity CFM
    • DOP test class C,B,A
    1. AHU Qualification
    • Differential Pressure for each Section (fan and Filters)
    • Air Flow Quantity CFM
    • Temperatures
    • Fan Speed- RPM
    • TAB
    • Motor Speed- rpm
    • DOP TEST
    • DOP test for HEPA filters
    • Static pressure
    1. LAF Qualification IQ, OQ & PQ
    • Air Velocity
    • T &RH%
    • DP
    • PC
    • Recovery
    • Visualization
    • DOP


    FAT includes:
    • Timers
    • Stop Watches
    • Gases Devices
    • 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)

    FAT includes:
    • 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).
    • Overall Review/Inspection.

    Site Acceptance Test (SAT)

    SAT includes:
    • Verification of equipment design
    • Specifications of received equipment at the site of User by received documents/drawings from Manufacturer / vendor
    • Physical verification

    Installation Qualification

    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.

    Operational Qualification

    • 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.

    Performance Qualification

    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.