Remove Public Health Remove Records Management Remove World Health
article thumbnail

Understanding WHO Guidelines for Batch Manufacturing Records

Dot Compliance

The World Health Organization (WHO) has established guidelines for BMRs to ensure consistency, quality, and safety across the global pharmaceutical industry. By following these guidelines, manufacturers can: Protect public health: Ensure that the products they produce are safe and effective for use. Get started now.

article thumbnail

SQA Regulatory Surveillance Summary for May and June 2024

SQA

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary for May and June 2024

SQA

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 40
article thumbnail

SQA Regulatory Surveillance Summary for January and February 2024

SQA

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