Provision 10747/2024 – New Regulations for Disposable Hygiene Products for External Use and Hygiene Products for Intravaginal Use

Key Regulatory Requirements:

1. Scope of GMP:

• Covers all stages of production: design, procurement, manufacturing, testing, packaging, labeling, and storage.
• Focuses on minimizing contamination risks and ensuring effective cleaning and maintenance.

2. Manufacturing Standards:

• Manufacturers must implement robust control systems.
• Quality control areas must be segregated to prevent cross-contamination.
• Unauthorized personnel are prohibited from accessing production, storage, or quality control areas.

3. Personnel Requirements:

• Adequate staffing is essential to meet quality standards.
• Staff should be trained to comply with GMP protocols.

4. Supplier and Record Management:

• Establish and maintain clear criteria for evaluating suppliers.
• Maintain historical product records for traceability and compliance.

5. Product Inspections and Testing:

• Conduct regular inspections and testing on semi-finished and finished products to ensure quality.

6. Outsourcing Controls:

• Define, approve, and monitor outsourced activities to prevent misunderstandings and ensure product quality.

These regulations aim to uphold high standards of safety, efficacy, and reliability for disposable hygiene products, safeguarding consumer health.

Region: Argentina
Source: https://www.argentina.gob.ar/noticias/nueva-normativa-para-productos-higienicos-descartables-de-uso-externo-y-productos
https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-10747-2024-406867
https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-10747-2024-406867/texto