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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA

In March 2022, Philips Health Systems informed the MHRA of an important safety issue due to potential unexpected shutdowns of all their V60 and V60 Plus non-invasive ventilators. V60 and V60 Plus devices are designed for in-hospital use. 88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 2022.