means (Schedule GMO/M contaminated 8:17) material /waste transported in leak proof containers Schedule Equipment / bedding / SOP for equipment decontamination? Y/N 8:15 Bedding cleaning protocol (e.g. high decontaminated or cleaned temperature wash)? Y/N before removal for repair /service / replacement Schedule Safe storage of GMM’s Restricted cupboards, fridges, freezers? Y/N 8:20 Controlled access in place ? Y/N Regulation Appropriate instruction and QMUL GMO safety course for clinical trial 18 Schedule staff provided by Biological Safety Adviser training on working with GM 7 (QMUL HSD) course code HS025 . material for staff Regulation Prohibition of mouth 18 Schedule pipetting, eating, drinking, 7 cosmetic application, using tobacco products, storing of food for human consumption in GM clinical areas GM Risk Assessment (RA) and Management of Work Regulation 5 Suitable and sufficient GM risk assessment for human health/exposure completed (assesses following guidance topics) Guidance GMO/M tracking system from receipt to Risk of occupational human destruction. Safe sharps handling policy and exposure minimized during procedure. Emergency procedure is place for GMO/M receipt, storage, accidents and incidents. preparation, transport, disposal Guidance Risk of occupational human SOP’s in place for patient care and handling exposure minimized during administration, patient handling, emergency situations, sampling / monitoring activities, interaction with family, visitors and staff Guidance Risk of occupational human SOP’s in place for waste inactivation and disposal exposure minimized during waste inactivation, transport, final disposal Guidance Any health surveillance requirements for staff identified in RA? Regulation 5 GMO/M classified and Containment Level specified in RA Regulation 8 RA approved by BGMSC (Regulation 7 Significant changes / & 14)
means (Schedule 8:17) GMO/M contaminated material /waste transported in leak proof containers Schedule 8:15 Equipment / bedding / decontaminated or cleaned before removal for repair /service / replacement SOP for equipment decontamination? Y/N Bedding cleaning protocol (e.g. high temperature wash)? Y/N Schedule 8:20 Safe storage of GMM’s Restricted cupboards, fridges, freezers? Y/N Controlled access in place ? Y/N Regulation 18 Schedule 7 Appropriate instruction and training on working with GM material for staff QMUL GMO safety course for clinical trial staff provided by Biological Safety Adviser (QMUL HSD) course code HS025 . Regulation 18 Schedule 7 Prohibition of mouth pipetting, eating, drinking, cosmetic application, using tobacco products, storing of food for human consumption in GM clinical areas GM Risk Assessment (RA) and Management of Work Regulation 5 Suitable and sufficient GM risk assessment for human health/exposure completed (assesses following guidance topics) Guidance Risk of occupational human exposure minimized during GMO/M receipt, storage, preparation, transport, disposal GMO/M tracking system from receipt to destruction. Safe sharps handling policy and procedure. Emergency procedure is place for accidents and incidents. Guidance Risk of occupational human exposure minimized during administration, patient handling, emergency situations, sampling / monitoring activities, interaction with family, visitors and staff SOP’s in place for patient care and handling Guidance Risk of occupational human exposure minimized during waste inactivation, transport, final disposal SOP’s in place for waste inactivation and disposal Guidance Any health surveillance requirements for staff identified in RA? Regulation 5 GMO/M classified and Containment Level specified in RA Regulation 8 RA approved by BGMSC (Regulation 7 & 14) Significant changes /
QMUL_HS_182_Sep-2018_Inspection-checklist-GM-Class-1-Clinical-Setting_V2.docx