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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.

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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
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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
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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