SQA

DECEMBER 16, 2022

This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. United States Food and Drug Administration (FDA) – Regulations and guidance. The FDA is issuing this guidance to provide clarity and predictability for software manufacturers on this topic.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

JULY 8, 2022

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. World Health Organization (WHO). of devices worldwide have experienced this problem. WHO Pharmaceuticals Newsletter, No.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52