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Regulatory Compliance Update Bulletin: Temperature Monitoring — September 2026

This month's bulletin covers PIC/S's newly adopted PI 006-4 recommendation on qualification and validation, effective 1 October 2026, which introduces new transport verification requirements for temperature data loggers. We also confirm — after checking FDA, CFIA, USDA FSIS, WHO, USP, MHRA, FSANZ, CDSCO, FSSAI, Philippines FDA, and Thailand FDA — that no other material regulatory changes affecting temperature monitoring occurred this period.

Regulatory Compliance Update Bulletin: Temperature Monitoring — August 2026

This bulletin covers six regulatory developments affecting temperature monitoring in August 2026: the EMA/PIC/S Annex 15 revision, the FDA's lot-level food traceability flexibility consultation, post-transition QMSR inspections under Compliance Program 7382.850, WHO PQS E006 electronic monitoring requirements for vaccine cold chain equipment, India's Revised Schedule M now fully in force, and cold chain licensing conditions in Thailand and the Philippines. Sources checked this period included the FDA, USDA FSIS, CFIA, WHO, USP, MHRA, FSANZ, EMA/PIC/S, CDSCO, FSSAI, the Philippines FDA and the Thai FDA.

Regulatory Compliance Update Bulletin: Temperature Monitoring — July 2026

This July 2026 bulletin covers key regulatory developments affecting temperature monitoring in food, pharmaceutical, and medical device sectors — including the FDA QMSR coming into force, FSMA Food Traceability Rule enforcement deferral, UKHSA vaccine cold chain wastage data, Health Canada GUI-0069 revisions, and proposed USP Chapter <1079.5>. Sources checked include FDA, USDA FSIS, UKHSA (UK Green Book), Health Canada, USP, MHRA, FSANZ, and ISO.

Regulatory Compliance Update Bulletin: Temperature Monitoring — June 2026

This June 2026 bulletin covers recent regulatory developments affecting temperature monitoring across food, pharmaceutical, and medical device sectors, including the FDA Food Traceability Rule extension, the FDA QMSR, USP <1079.2>, Health Canada GUI-0069, and USDA FSIS Salmonella performance standards. Sources checked include FDA, CFIA, USDA FSIS, WHO, USP, MHRA, FSANZ, and ISO.