Warehouse Services

cGMP (Current Good Manufacturing Practice) CRT (Controlled Room Temperature) warehouse storage refers to the specialized storage of pharmaceutical, biological, and medical device products in a regulated environment where temperatures are consistently maintained between 20°C and 25°C. Quality Systems Integrations’ facility operates under strict compliance with cGMP guidelines established by regulatory authorities such as the FDA and EMA. The primary goal is to ensure the safety, efficacy, and quality of temperature-sensitive products by implementing advanced climate control systems, robust quality management practices, and rigorous security protocols. This type of storage is essential for preserving the integrity of medications, vaccines, biologics, and other healthcare products throughout the supply chain. The storage and distribution of pharmaceutical products require specialized facilities designed to meet stringent regulatory and quality standards. Quality Systems Integration (QSI) offers a cGMP-controlled room temperature (CRT) warehouse solution, purpose-built to maintain the integrity and safety of pharmaceutical, biological, and medical products while supporting efficient supply chain operations. Below are several reasons why clients rely on Quality Systems Integration for CRT Warehouse Storage.

Regulatory Compliance

The cGMP CRT warehouse adheres to the highest industry standards, including FDA and EMA requirements, as well as Good Distribution Practices (GDP). Rigorous protocols ensure that every product stored meets regulatory guidelines for quality, safety, and efficacy.

Precise Temperature Control

A controlled room temperature environment, maintained consistently between 20°C and 25°C, is critical for storing sensitive pharmaceuticals such as biologics and vaccines. QSI’s advanced climate control systems, supported by real-time monitoring and backup mechanisms, guarantee optimal conditions to preserve product integrity.

    • CRT (20 °C to 25 °C)
    • Ambient (15 °C to 30 °C)
    • Refrigerated (2 °C to 8 °C)
    • Frozen (-15 °C to -30 °C)
    • Ultra Low Frozen (-70 °C to -90 °C)
    • ICH (various) accelerated age temperature and humidity

Advanced Inventory Management

Validated inventory tracking systems provide precise monitoring of stock levels, batch control, and expiration dates. These systems facilitate first-in, first-out (FIFO) rotation, ensuring proper product management and reducing waste.

Stringent Security Measures

Given the high value and sensitivity of pharmaceutical products, the facility is equipped with robust security protocols, including 24/7 CCTV surveillance, controlled access systems, and regular audits. These measures protect against theft, tampering, and unauthorized access.

Integrated Logistics and Distribution

Efficient logistics capabilities enable seamless coordination with transportation providers for timely distribution of products. This includes maintaining the required conditions during transit to ensure compliance with storage standards throughout the supply chain. QSI 3PL Plus has a partnering solution for both domestic and international product movement. Our goal is to work with our customers’ schedules to provide on-time delivery every time.

Quality Systems, Training and Documentation

QSI 3PL Plus staff participate in a rigorous training program that focuses on warehouse safety, good documentation practices and inventory management. All staff members are extensively trained in the handling and storage of pharmaceutical products, emergency protocols, and adherence to regulatory requirements.

Supporting Critical Needs in the Pharmaceutical Industry

With the specialized infrastructure, technical expertise, and unwavering commitment to regulatory compliance, QSI’s cGMP CRT warehouse provides a reliable solution for pharmaceutical companies requiring secure, temperature-controlled storage. By ensuring product safety and quality, the warehouse plays a vital role in supporting the global supply chain for life-saving medications and treatments.

Redundant Systems

QSI 3PL Plus facility has designed redundancy into their process by use of validated emergency generators. The CRT facility also has redundant HVAC components in cases where mechanical failure occurs. The facility has been validated to maintain CRT environmental conditions with only two of the three rooftop HVAC units operating.