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Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2)

Australia (Commonwealth, with corresponding State legislation)
vVersion 3.2, effective 1 March 2013 (current as at 2026-10-21; the OGTR annual inspection checklist of May 2023 and application checklist of December 2020 still cite it)
3 domains
65 controls

Australia's PC2 laboratory certification rules from the Gene Technology Regulator: facility requirements for certification, the usual conditions of certification (access, annual inspection, signage, cabinet testing, decontamination equipment, backflow) and the behavioural requirements for people handling GMOs.

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Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) is a compliance framework from Australia (Commonwealth, with corresponding State legislation) with 3 domains and 65 controls. The largest domains are Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) (31 controls), Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) (23 controls), Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) (11 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard Blokdyk

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Framework Domains (3)

Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2)

11 controls
Controls in the Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) domain of Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2): 11 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A1Enclosable and securable space
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A10Ability to meet the conditions of certification
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A11Floor plans with the application
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A2Smooth, water-proof, cleanable and resistant surfaces
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A3Open spaces reachable for decontamination
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A4Hand decontamination
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A5Eyewash inside the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A6Containment of aerosols
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A7Backflow: facility already meets AS/NZS 2243.3
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A8Backflow assessment where AS/NZS 2243.3 is not met
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::A9Place for personal protective equipment

Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2)

31 controls
Controls in the Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) domain of Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2): 31 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B1Access limited to authorised persons
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B10Work not allowed in a PC2 laboratory
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B11Notifying the Regulator when an owner fails to maintain
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B12Inspection at least every 12 months
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B13Signs at each access door
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B14Decontaminants available, labelled and in date
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B15Pest control strategy
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B16Keeping the Part A requirements met
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B17Before structural changes
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B18Lifting a suspension
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B19Testing biological safety cabinets
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B2Who counts as an authorised person
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B20Test certificate on the cabinet
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B21Cabinet that fails its test
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B22Monthly monitoring and annual calibration of heat-based decontamination
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B23Users can see the decontamination equipment status
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B24Defective decontamination equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B25Maintaining backflow prevention measures
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B26Backflow assessment where none was done before
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B27Reviewing the backflow assessment
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B28Fitting backflow prevention after a review
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B29Keeping the backflow records
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B3Training records on the Regulator's request
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B30Annual testing of testable backflow devices
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B31Faulty backflow device
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B4Excluding a person on the Regulator's direction
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B5Conditional admission on the Regulator's direction
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B6Telling people their admission conditions
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B7Submissions on exclusion or conditional admission
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B8Authority to admit and exclude where the holder is not the owner
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::B9Entry for the Regulator

Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2)

23 controls
Controls in the Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) domain of Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2): 23 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C1Who must follow the behavioural requirements
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C10Decontamination methods
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C11Trained people decontaminate
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C12Decontaminate before disposal
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C13Decontaminating benches and equipment after work
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C14Decontaminating equipment before it leaves
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C15Removing and treating protective equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C16Hand decontamination on leaving
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C17Written spill procedures
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C18Dealing with a spill inside
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C19Escape or loss outside the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C2Non-GMO, exempt and PC1 work in the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C20Decontamination to the guidelines
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C21Labelling GMO containers
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C22Transport and storage outside the facility
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C23Sealed storage of cultures
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C3Doors closed and secured
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C4Emergency exits
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C5Windows closed and secured
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C6Aerosol-generating work in a cabinet
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C7Using and decontaminating cabinets
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C8Protective clothing and gloves
australia-ogtr-guidelines-for-certification-of-a-pc2-laboratory-version-3-2::C9Wearing protective equipment between facilities

What is Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) and who does it apply to?

Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) is a compliance framework from Australia (Commonwealth, with corresponding State legislation) with 3 domains and 65 controls. Australia's PC2 laboratory certification rules from the Gene Technology Regulator: facility requirements for certification, the usual conditions of certification (access, annual inspection, signage, cabinet testing, decontamination equipment, backflow) and the behavioural requirements 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 Laboratory (Version 3.2) actually require?

Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) has 65 controls organised across 3 domains. The largest domains are Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) (31 controls), Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) (23 controls), Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) (11 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 Laboratory (Version 3.2) do I already cover?

Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) 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 Laboratory (Version 3.2)?

Start your Australia OGTR Guidelines for Certification of a PC2 Laboratory (Version 3.2) 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 Laboratory (Version 3.2) 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 65 controls and track your progress.

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