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The WorldHealth 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.
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.
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