SQA

AUGUST 2, 2021

ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

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for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.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

SQA

JULY 8, 2022

88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 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. PDA Technical Report No.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40