Sao Nam & PMS – Giải pháp toàn diện phòng sạch dược phẩm đạt chuẩn EU GMP

Sao Nam & PMS – Giải pháp toàn diện phòng sạch dược phẩm đạt chuẩn EU GMP

1. Tiêu chuẩn EU GMP và FDA yêu cầu những gì cốt lõi đối với Giám sát Môi trường?

2. Giải pháp từ Particle Measuring Systems (PMS - Mỹ) bao gồm những hệ thống nào?

3. Sao Nam có năng lực và kinh nghiệm ra sao trong việc triển khai hệ thống cho nhà máy đạt chuẩn EU GMP?

Cần tư vấn giải pháp phòng sạch và giám sát môi trường?

1. Context and Challenges

Regulatory bodies worldwide, such as the FDA and EMA (EU GMP), are increasingly tightening standards for Environmental Monitoring. At the core of this trend, pharmaceutical manufacturing plants are required to establish a comprehensive, transparent contamination control and data management strategy.

2. Comprehensive Solutions from PMS - USA

To support pharmaceutical plants in meeting rigorous inspection standards, Particle Measuring Systems (PMS - USA) provides end-to-end solutions based on the "Sterility Assurance" model, continuously supported by the "Data Management" lifecycle.

3. Key Pillars of the PMS Ecosystem

This ecosystem is built upon four robust pillars:

• Contamination Monitors: Providing advanced portable and remote particle counters and microbial samplers.
• Environmental Monitoring Systems (EMS): Integrating central control systems, data management software, and automated sampling workflows.
• Services: Offering GMP compliance consulting, calibration, maintenance, validation, and professional installation.
• Training and Education: Delivering specialized academic resources and regular certified webinars to enhance plant personnel capabilities.

4. Authorized Representation & Local Expertise in Vietnam

As an official authorized distributor of PMS for over 10 years in Vietnam, Sao Nam has successfully deployed environmental monitoring systems for more than 50 pharmaceutical facilities, proudly accompanying 15 out of 24 EU GMP-certified enterprises.

5. Advanced Technical Capabilities

Beyond equipment supply, Sao Nam directly executes specialized technical services including calibration, maintenance, IQ/OQ/PQ validation, and technical support. We are committed to maintaining stable system performance, precise data integrity, and strict compliance with EU GMP standards.

6. Commitment & Strategic Partnership

Anchored by the philosophy of "Standards – Precision – Sustainability", the synergy between world-class technology from PMS and Sao Nam's practical expertise since 2009 solidifies our position as your strategic technical partner, supporting you from solution consulting and system installation to comprehensive operation and maintenance.