About Cryopak Assurance Solutions

quality assurance cryopakCryopak’s Regulatory Compliance business unit was created to help life sciences and health care companies meet the increasing regulatory standards and guidelines that the industry is facing today. This division not only helps our customers meet the increasing regulatory compliance but also helps to reduce the cost of getting their products to market, as well as reduce overhead costs. The products and services that are offered by our Compliance Systems division provide compliance solutions to the following standards and guidelines:

  • PDA TR 39 & 52
  • U.S. Pharmacopeia (USP) 1079, Good Storage & Shipping Practices
  • USP 1083 Good Distribution Practices-Supply Chain Integrity
  • WHO drug stability standards
  • ICH drug stability standards
  • FDA cGMP framework

These increasingly strict standards and guidelines demand extensive knowledge and require a large service offering to fully comply. Cryopak has extensive knowledge and understanding of these standards and in turn created a diverse product and service offering to meet the needs of cold chain supply.

Products & Services

Regulatory Compliance Services include:

  • Cold Chain Process Analysis
  • Cold Chain Quality and Gap Analysis Audit; Visit; Report & Recommendations

Regulatory Support, Documentation and Training:

  • Personnel Training, Cold Chain Quality and Compliance
  • Assistance for Quality Documentation, SOP writing.

Temperature Distribution Mapping Services:

  • Equipment Mapping
  • Warehouse Mapping, (summer, winter)
  • Truck-trailer mapping (Vehicles)

Temperature Profile Study of Shipping Lanes:

  • Ambient Temperature Profile Study & Analysis (summer, winter)

Validation & Qualification:

  • Qualification (IQ/OQ/PQ) of thermal facilities, equipment and vehicles.

Temperature & HumidityMonitoring Systems (web based and self hosted products)

  • Transportation and secondary packaging for the cold chain
  • Facility and Cold Storage warehouse monitoring
  • Equipment monitoring
  • Tractor trailer and container monitoring

Cryopak Quality Assurance

New Jersey
551 Raritan Center Parkway
Edison, NJ 08837
Phone: 732-346-9200
Fax: 732-346-0295

6818 Jarry St. East
St. Leonard, QC H1P 1W3
Phone: 514.324.4720
Fax: 514.324.9623

6 rue Denis Papin
ZI la Maine
76150 Maromme, France
Tel: +33(0) 2 32 82  59 65
Fax: +33(0) 2 32 82 59 66

Contact Us

Web: www.cryopak.com
Email: sales@cryopak.com