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Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1)

Australia (Commonwealth, with corresponding State legislation)
vVersion 3.1, issued 28 February 2018 (current as at 2026-10-21; the OGTR annual inspection and application checklists for a PC2 Large Scale Facility are written against it, listed February 2018 on the OGTR page (current files dated May 2023))
2 domains
95 controls

Australia's PC2 large scale facility certification rules from the Gene Technology Regulator: facility, closed system, secondary containment and liquid waste treatment requirements, the usual conditions of certification (access, annual inspection, integrity, cabinet, backflow and decontamination equipment testing, training) and the work practices for people handling GMOs.

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Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) is a compliance framework from Australia (Commonwealth, with corresponding State legislation) with 2 domains and 95 controls. The largest domains are Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) (68 controls), Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) (27 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard Blokdyk

Framework summaries on this platform are interpretations grounded in the published source, for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (2)

Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1)

27 controls
Controls in the Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) domain of Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1): 27 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R1Enclosable and securable work area
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R10Risk assessment for other reticulated services
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R11Backflow measures where the assessment calls for them
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R12Documenting the backflow assessment
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R13Spill procedures and means for the work area
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R14Closed systems for large scale cultures
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R15Closed systems designed to prevent release
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R16Single-use components testable for leaks
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R17Securing and removing large bioreactor bags
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R18Decontaminating single-use components without release
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R19Decontaminating reusable closed systems without release
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R2Openings filtered or screened against animals
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R20Reusable closed systems testable for integrity
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R21Respiratory protection risk assessment
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R22Biological safety cabinet where aerosols are produced
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R23Other processing equipment able to contain GMOs
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R24Secondary containment for the closed system
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R25Liquid waste treatment system located outside the work area
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R26Ability to meet the conditions of certification
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R27Documents lodged with the application
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R3Smooth, water-proof, cleanable and resistant surfaces
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R4Open spaces reachable for decontamination
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R5Liquid effluent from sinks and floor drains
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R6Hands-free hand decontamination
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R7Emergency drench shower and eyewash
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R8Place for reusable protective clothing
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::R9Backflow protection of the water supply

Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1)

68 controls
Controls in the Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) domain of Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1): 68 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C1Work not permitted in the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C10Telling people their admission conditions
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C11Submissions on exclusion or conditional access
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C12Authority to admit and exclude where the holder is not the owner
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C13Entry for the Regulator
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C14Pest prevention strategy
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C15Inspection at least every 12 months
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C16Keeping the containment equipment requirements met
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C17Keeping the LWTS requirements met
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C18Before structural changes
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C19Inspection before a suspension is lifted
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C2Keeping the facility and fittings requirements met
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C20No dealings until the suspension is lifted
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C21Integrity testing of reusable closed systems
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C22Reusable closed system that fails its test
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C23Integrity testing of single-use components
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C24Single-use component that fails its test
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C25Monitoring and calibrating heat-based decontamination equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C26Monitoring and inspecting the LWTS
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C27Testing biological safety cabinets
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C28Cabinet that fails its test
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C29Annual testing of testable backflow devices
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C3Signs at each entry point
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C30Faulty backflow device
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C31Training before dealings
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C32Content of the training
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C33Doors closed and locked
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C34Windows closed
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C35Gloves off and hands decontaminated before leaving
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C36Personal protective equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C37Removing protective equipment before leaving
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C38Aerosol-producing work in a cabinet
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C39Installing and using cabinets
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C4Disinfectants available and labelled
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C40Sampling, additions and transfers without release
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C41Process waste decontamination method lodged first
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C42Decontamination without release
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C43In situ decontamination of closed systems
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C44Trained people decontaminate
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C45Decontaminating benches, surfaces and equipment after dealings
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C46Decontaminating before maintenance
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C47Decontaminating liquid and solid waste
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C48Decontaminating filters before disposal
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C49GMOs made non-viable before disposal
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C5Keeping the facility management requirements met
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C50Decontaminating equipment before it leaves
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C51Removing and treating contaminated protective equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C52Decontamination methods
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C53Chemical treatment effective against the GMO
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C54Validated time and temperature for heat treatment
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C55Telling processed loads from unprocessed
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C56Decontamination equipment status labelled
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C57Defective decontamination equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C58Decontaminating cabinets
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C59Spill inside the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C6Access limited to authorised persons
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C60Spill outside the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C61LWTS failure causing a spill outside the work area
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C62Labelling GMO containers
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C63No removal of over 25 litres without permission
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C64Removing 25 litres or less
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C65Storing 25 litres or less outside the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C66Removing non-GMOs while dealings are under way
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C67Incidents reported to the Regulator
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C68Records kept for five years or as long as relevant
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C7Supervising non-dealing entrants
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C8Excluding a person on the Regulator's direction
australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C9Conditional admission on the Regulator's direction

What is Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) and who does it apply to?

Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) is a compliance framework from Australia (Commonwealth, with corresponding State legislation) with 2 domains and 95 controls. Australia's PC2 large scale facility certification rules from the Gene Technology Regulator: facility, closed system, secondary containment and liquid waste treatment requirements, the usual conditions of certification (access, annual inspection, integrity, cabinet, backflow and decontamination equipment testing, training) and the work practices for people handling GMOs. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

What does Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) actually require?

Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) has 95 controls organised across 2 domains. The largest domains are Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) (68 controls), Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) (27 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) do I already cover?

Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.

How do I implement Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1)?

Start your Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 95 controls and track your progress.

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