SQA

OCTOBER 18, 2024

The establishment’s document control/record management system was not sufficient. It provides a summary of the changes in GMP requirements resulting from the recent replacement of the PIC/S Guide to GMP for Medicinal Products (PE 009-15, 01 May 2021) with PE 009-16, 01 February 2022. All other changes are minor (i.e.,

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

The establishments document control/record management system was not sufficient. It provides a summary of the changes inGMP requirements resulting from the recent replacement of the PIC/S Guide to GMP for Medicinal Products(PE 009-15, 01 May 2021) with PE 009-16,01 February 2022.The All other changes are minor (i.e.,

FDA 40

FDA Compliance Public Health Governance 40

SQA

JUNE 3, 2024

A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety. Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules.

FDA 40

FDA COVID-19 Licensing Nurses 40