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Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1)

Australia (Commonwealth, with corresponding State legislation)
vVersion 2.1, effective 9 August 2011 (current as at 2026-10-21 per the OGTR collection page capture of that date; the OGTR annual inspection checklist, checklist PDF dated 9 May 2023 (file metadata; the collection page lists it as October 2011), still cites it)
3 domains
46 controls

Australia's PC2 constant temperature room certification rules from the Gene Technology Regulator: facility requirements for certification, the usual conditions of certification (access, inspection at least every 12 months, signage, dealings not permitted, heat-based decontamination equipment) and the behavioural requirements for people handling GMOs.

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Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) is a compliance framework from Australia (Commonwealth, with corresponding State legislation) with 3 domains and 46 controls. The largest domains are Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) (22 controls), Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) (19 controls), Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) (5 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 Constant Temperature Room (Version 2.1)

5 controls
Controls in the Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) domain of Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1): 5 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::A1Enclosable and securable space
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::A2Smooth, water-proof, cleanable and resistant surfaces
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::A3Open spaces reachable for decontamination
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::A4Ability to meet the conditions of certification
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::A5Floor plans with the application

Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1)

22 controls
Controls in the Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) domain of Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1): 22 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B1Access limited to authorised persons
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B10Work not allowed in a PC2 constant temperature room
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B11Notifying the Regulator when an owner fails to maintain
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B12Inspection at least every 12 months
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B13Signs at each access door
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B14Decontaminants available, labelled and in date
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B15Pest control strategy
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B16Keeping the Part A requirements met
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B17Before significant structural changes
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B18Lifting a suspension
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B19Part of the facility excluded by variation
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B2Who counts as an authorised person
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B20Monitoring the effectiveness of heat-based decontamination
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B21Calibrating heat-based decontamination equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B22Defective decontamination equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B3Training records on the Regulator's request
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B4Excluding a person on the Regulator's direction
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B5Conditional admission on the Regulator's direction
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B6Telling people their admission conditions
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B7Submissions on exclusion or conditional admission
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B8Authority to admit and exclude where the holder is not the owner
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::B9Entry for the Regulator

Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1)

19 controls
Controls in the Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) domain of Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1): 19 controls
CodeTitle
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C1Non-GMO, exempt and PC1 work in the room
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C10Decontaminating benches, surfaces and equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C11Decontaminating equipment before it leaves
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C12Removing and treating contaminated protective equipment
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C13Decontamination methods
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C14Hand decontamination before leaving
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C15Written spill procedures
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C16Dealing with a spill inside
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C17Labelling GMO containers
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C18When GMOs may leave the room
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C19Transport, storage and disposal outside the room
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C2Doors closed and secured, emergency exits
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C3Windows closed and secured
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C4GMOs kept in sealed primary containers
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C5Removing protective equipment before leaving
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C6Where decontamination takes place
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C7Authorised personnel decontaminate
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C8Decontaminating GMOs before disposal
australia-ogtr-guidelines-for-certification-of-a-pc2-constant-temperature-room-version-2-1::C9Decontaminating GMO waste before disposal

What is Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) and who does it apply to?

Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) is a compliance framework from Australia (Commonwealth, with corresponding State legislation) with 3 domains and 46 controls. Australia's PC2 constant temperature room certification rules from the Gene Technology Regulator: facility requirements for certification, the usual conditions of certification (access, inspection at least every 12 months, signage, dealings not permitted, heat-based decontamination equipment) 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 Constant Temperature Room (Version 2.1) actually require?

Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) has 46 controls organised across 3 domains. The largest domains are Part B: Conditions of certification – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) (22 controls), Part C: Behavioural requirements – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) (19 controls), Part A: Requirements for certification – Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) (5 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 Constant Temperature Room (Version 2.1) do I already cover?

Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) 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 Constant Temperature Room (Version 2.1)?

Start your Australia OGTR Guidelines for Certification of a PC2 Constant Temperature Room (Version 2.1) 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 Constant Temperature Room (Version 2.1) 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 46 controls and track your progress.

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