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SQA Regulatory Surveillance Summary | Monthly Update 2024

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for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.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
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

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
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