MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS .


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2. GMP Manufacturing Environments. Air Handling SystemsHVAC Systems Heating Ventilation Air ConditioningModule 5: Validation, Qualification
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MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS Module 5 Presented by : Deryck Smith Consulting Engineers

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GMP Manufacturing Environments Air Handling Systems HVAC Systems H eating V entilation An ir C onditioning Module 5: Validation, Qualification & Maintenance

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Validation/Qualification of HVAC Systems Topics for this Module: The definition and requirement for approval of HVAC Systems A capability approach for HVAC Systems Retrospective capability Inspection of HVAC Systems Maintenance of HVAC Systems 

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Validation/Qualification of HVAC Systems Definition of Validation : The archived demonstration of demonstrating that any strategy, prepare, gear, material, action or framework, really prompts to the normal outcomes.

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Validation/Qualification of HVAC Systems PIC/S Definition of Validation : Action of demonstrating, as per the standards of Good Manufacturing Practice , that any technique, prepare, hardware, material, movement or framework really prompts to the normal outcomes.

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Validation or Qualification of a HVAC System ? Capability : The activity of demonstrating that any gear works effectively and really prompts to the normal outcomes.

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Validation or Qualification of a HVAC System ? A framework must be fit the bill to work in an approved procedure Equipment and frameworks are qualified A procedure is approved various frameworks make up a procedure 

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Qualification/Validation Issues A decent outline is fundamental, however it must be supplemented by: Qualification of air dealing with frameworks Process approval Maintenance and occasional re-capability Adequate documentation 

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A Qualification approach for HVAC frameworks Key Definitions : DQ - Design Qualification IQ - Installation Qualification OQ - Operational Qualification PQ - Performance Qualification VMP - Validation Master Plan GEP - Good Engineering Practice 

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A Qualification approach for HVAC Systems A Validation Master Plan User prerequisite report Design Qualification Installation Qualification Operational Qualification Performance Qualification

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A Qualification approach for HVAC frameworks Qualification requires : Collaboration of specialists Budget Planning 

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A Qualification approach for HVAC frameworks Planning : Which frameworks are basic/non-basic ? (Chance appraisal) Direct or roundabout effect (ISPE) Which parts of the framework will be qualified ? Which parts of the framework will be taken care of under GEP ? These choices have suggestions on the degree, cost and time of the capability procedure.

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A Qualification approach for HVAC Systems Critical versus non-basic frameworks : (Risk or Impact appraisal) Impact appraisal Critical part Non-basic segment ISPE Definition: Impact appraisal is the procedure by which the effect of a framework on item quality is assessed and the basic segments inside those frameworks are recognized. 

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Critical Components A basic part inside a framework where the operation, contact, information, control, alert or disappointment will directly affect the nature of the item. Eg. Supply air fan in an AHU, HEPA channels, HVAC control framework. 

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Non-basic Components A non-basic segment inside a framework where the operation, contact, information, control, alert or disappointment will have an in-direct, or no effect on the nature of the item. Eg. Principle office chiller, Eskom high strain transformer on location. 

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A Qualification approach for HVAC Systems Model for "Direct Impact" frameworks PQ Test Plan Performance Qualification User Requirement (ie. What) OQ Test Plan (inc.FAT) Operational Qualification Functional Design (ie. How as schematic) Design Development IQ Test Plan (inc.PDI) Installation Qualification Detail Design (ie. The most effective method to make) Impact Assessment Implementation ISPE Baseline Guide Vol.5

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A Qualification approach for HVAC Systems Model for "Circuitous Impact" frameworks Commissioning Plan Performance Testing User Requirement (ie. What) (inc.FAT) Functional Design (ie. How as schematic) Setting-to-work & Testing Regulation & Adjustment Design Development (inc.PDI) Physical Completion & Inspection Detail Design (ie. Step by step instructions to make) Impact Assessment Implementation ISPE Baseline Guide Vol.5

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A Qualification approach for HVAC Systems The Validation Master Plan Validation strategy Organizational structure of approval exercises Summary of offices, frameworks, gear and procedures to be approved Documentation arrangement to be utilized for conventions and reports Planning and booking Change control References to existing archives  This record ought to contain : Ref : PIC/S Annex.15

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A Qualification approach for HVAC Systems User necessity particular (URS) What operational prerequisites are there ? Required room temperatures and relative humidities Cleanroom orders for the ranges Single pass or re-flowed HVAC frameworks ? Room weights/Air stream bearings GMP necessities 

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A Qualification approach for HVAC Systems DESIGN QUALIFICATION (DQ) First step in the capability of new HVAC frameworks. It archives the outline of the framework and will incorporate : Functional Specification. Specialized/Performance particular for gear. Itemized Air Flow Schematics. Nitty gritty format drawing of the system. 

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A Qualification approach for HVAC Systems An altogether executed DQ prepare guarantees the accompanying : Compliance with GMP\'s and other administrative prerequisites. Configuration meets the client prerequisites. Configuration subtle elements office wind stream and weight course theory. Configuration considers process and staff stream (cross-sullying issues) Design subtle elements materials of development. Configuration subtle elements wellbeing necessities. Full subtle elements of the proposed development preceding usage. Subtle elements all gear that must be requested.  ISPE Baseline Guide Vol.5

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A Qualification approach for HVAC Systems Installation Qualification (IQ) The objective of IQ is to confirm and report the quality, establishment and respectability of the HVAC framework. Execution of IQ conventions gives confirmation that a HVAC framework is introduced as per the qualified outline. IQ ought to highlight disparities between outline formats itemized in the DQ and what has been developed (\'As-fabricated" status) 

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A Qualification approach for HVAC Systems IQ ought to incorporate, however not be constrained to the accompanying : Installation of hardware, funneling, administrations and instrumentation checked against current building drawings and particulars Collection and examination of provider working and working directions and support prerequisites Calibration of measuring instruments necessities Verification of materials of development  Ref : PIC/S Annex.15

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A Qualification approach for HVAC Systems Practical parts of IQ : Design drawings can be increased and deviations highlighted. DQ to be finished and closed down before IQ starts. IQ conventions to be composed and affirmed preceding execution. Check records for segments to be introduced can be utilized. Things, for example, fans, fan engines, cooling and warming loops, channels, temperature and relative stickiness sensors and differential weight gages can be incorporated into check records. Conduit and pipe weight test reports. Channel uprightness tests. Usefulness Loop checks and alert tests for HVAC control frameworks. 

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A Qualification approach for HVAC Systems Practical parts of IQ (cont.) : Calibration of measuring instruments. Adjustment of furthermore utilized instruments. Starting cleaning records. Essential dispatching checks. Upkeep prerequisites. IQ handle watches that the right parts are introduced in the right area. Materials of development Spare parts Change controls 

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An altogether executed IQ prepare guarantees the accompanying : A completely checked establishment that consents to the archived plan. (all deviations will have been recorded and surveyed.) All gear documentation and support necessities would be reported. Finished alignment of measuring instruments. Materials of development would have been checked. 

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Operational Qualification (OQ) The reason for OQ is to confirm and record that a HVAC framework gives satisfactory operational control under "very still" conditions. ISPE definition : The motivation behind OQ is to build up, through reported testing, that every basic segment are equipped for working inside set up points of confinement and resistances. 

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Operational control/operation inside set up breaking points and resiliences can be exhibited by any of the accompanying : Ability to look after temperature, relative moistness and weight set focuses. Capacity to give demeanor of adequate quality and amount to guarantee accomplishment of indicated cleanroom conditions. Capacity to keep up any basic parameters expressed in the DQ reliably. 

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Operational Qualification ought to incorporate, however not be constrained to the accompanying : Tests that have been produced from learning of procedures, frameworks and gear. Tests to incorporate a condition or an arrangement of conditions including upper and lower working points of confinement, at times alluded to as \'thinking pessimistically\' conditions.  Ref : PIC/S Annex.15

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Practical parts of OQ : IQ reports must be finished and closed down. OQ conventions to be composed and affirmed before finishing. Estimation reports are required to show accomplishment of basic parameters as point by point in DQ. Eg: * Temperature estimation report * Humid

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