Remove 2027 Remove Compliance Remove World Health
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The electronic certificate and the paper version are equally authentic.

article thumbnail

SQA Regulatory Surveillance Summary for May and June 2024

SQA

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

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

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 40
article thumbnail

SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

Establishing a Program for the Union’s Action in the Field of Health (EU4Health Programme) for the Period of 2021-2027, Regulation (EU) 2021/522, 24 March 2021. Regulation (EU) 2021/522 establishes a new and reinforced program for the Union’s action in the field of health, called the EU4Health Programme , for the period of 2021-2027.