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

Australia OGTR Guidelines for Certification of a PC2 Large Scale Facility (Version 3.1) C68: Records kept for five years or as long as relevant

What does C68 require?

Records of the actions other conditions require must be made, kept for five years from creation unless stated otherwise, and given to the Regulator if asked for: (a) training records and authorised persons' signed statements; (b) the pest prevention strategies and the pest control work done; (c) the facility's annual inspection; (d) integrity testing of closed systems, reusable and single-use; (e) monthly and annual monitoring and calibration results for each autoclave or other heat-based unit used to decontaminate GMOs, the LWTS included if there is one; (f) evidence that process waste decontamination methods work; (g) test results for each installed Class I or II biological safety cabinet used for GMO dealings; (h) test results for any testable backflow prevention devices (under AS/NZS 3500.1); (i) maintenance results for any LWTS; (j) documentation of any backflow prevention risk assessment, kept for as long as relevant; and (k) documentation of any assessment of operator aerosol exposure during closed system work, kept for as long as relevant. The guideline explains that 'as long as relevant' lasts until another risk assessment is done or the facility stops being certified.

Maintained by Gerard Blokdyk

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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.