Main Regulations for QA/QC Labs
Regulations are changing quickly to improve patient, consumer, and environmental protection. QC and QA managers need to stay informed about these changes and understand their impact on laboratory equipment, even with busy schedules and administrative tasks.
Sartorius breaks down the key regulations affecting QA/QC labs and provides easy-to-follow guidance for adapting to and implementing these changes.
Regulatory Compliance Applications
Discover Compliant Solutions for Your Lab
Cubis® II Balances, Your Ally for Audit Preparedness
Lab balances are essential in QC/QA labs for various applications. Undetected errors can lead to analytical biases and extensive document reviews.
Cubis® II balances help you meet regulatory requirements and support your daily analytical protocols.
- Low minimum sample weight per USP <41>, EP 2,1,7, JP 9,62
- Simplified cleanability and seamlessly adaptation to environmental conditions that follow USP <1251> recommendations
- Technical controls needed for 21 CFR part 11 compliance included on all Cubis® II MCA balances
Compliant Lab Services
Enhance performance and ensure compliance with Sartorius' comprehensive services for microbiology instruments, lab balances, water purification systems, and liquid handling products.
- Microbiology Instrument Services: Improve safety and reliability with support for MD8 air samplers and Sterisart® Pumps
- Lab Balances and Weighing Services: Achieve accurate results and extend equipment life with certified services, ensuring audit security and data accuracy
- Water Purification and Liquid Handling Services: Maintain high-quality lab water and precise pipetting with tailored service options for consistent performance
Microsart@filter to Monitor your Microbial Burden
Maintaining microbial control during drug substance (DS) or medical device (MD) processing is crucial to prevent product variability that can impact safety, potency, or purity. Both sterile and nonsterile products require strict microbial control to avoid contamination, focusing on raw materials, equipment, purified water, and environmental controls, as guided by regulations like EU GMP Annex 1.
- Combines funnel, filter base, and membrane in one unit. Available in 100 ml and 250 ml with various pore sizes and colors
- Features marked graduations, optimal rinsing, and Click-Fit closure. Available in sterile trays or bags for safe handling
- Ensures reliable and compliant results with minimal contamination, meeting USP, EP, and ISO standards
Sartorius Expertise in Regulatory & Compliance
A team of field and virtual experts assists you in understanding regulatory changes and their impact on your specific laboratory activities.
Sartorius collaborates with experts and peers in various working groups, sharing its expertise to draft and update international and regional standards.
Sartorius laboratory equipment, consumables, and services comply with current regulations, and our software updates ensure devices remain up-to-date with regulatory standards.
Resources for Pharmaceutical Compliance
Featured Resources
Frequently Asked Questions
Sartorius offers regulatory-compliant lab equipment, including precision balances, pipettes, sterility testing pumps, lab water systems, and biologics analytical systems, ensuring accurate results and adherence to industry standards.
Sartorius provides integrated lab software solutions for seamless data management, enhancing traceability and compliance with regulatory requirements.
Maintain Sartorius instruments with regular calibration and service plans, ensuring accuracy and reliability to minimize downtime in your lab.
Sartorius promotes sustainability with eco-friendly lab products, reducing waste and energy consumption to help labs align with environmental protection goals.
Discover Sartorius Commitment to Product Sustainability
Sartorius offers comprehensive training programs and resources to keep your team updated on the latest lab technologies and best practices.