Working with your current transportation, logistics, security, and quality management teams, 7P will develop a customized and comprehensive cold chain shipment solution and standard operating procedures to fit your product’s distribution, security, quality and compliance requirements.
Our quality management system can include proper temperature management, monitoring and in-transit visibility, climate control audits, and more. We can perform climate control and security audits on your current transportation solution providers to ensure they meet external regulations as well as your company’s requirements.
Security protocols are confidential between 7P and those who need to know within each client, Training is provided in accordance with our QMS and based on the job title and level of knowledge required for each job description to ensure compliance to internal security protocols.
We operate under the guidelines of cGMP, GDP, U.S. Pharmacopeia 1079, the Parental Drug Association, the World Health Organization and IATA Chapter 17 and the Food Safety Modernization Act to standardize your supply chain. Our specialized compliance team will work with you to establish and implement standard operating procedures.
Staff under the implementation of a QMS program are trained in accordance with their job descriptions and associated duties. In addition to their job duties, in general all staff members involved in the pharmaceutical cold chain will be trained on the following:
GxP, which covers a host of items related to Good Manufacturing Practices (GMP) Good Distribution Practices (GDP) and Good Storage Practices (GSP).
The Perishable Cold Chain Regulations which became mandatory on the 1st of July 2012 (IATA Chapter 17 PCR)
Universal Precautions for those handling shipments that could be harmful if damaged.
Audits of the entire cold chain
Quarterly audits, external and internal
Consistent QMS monitoring
Management of SOPs
Supply chain security audits
Security protocol development and implementation
Implement QMS across all service providers
Self-assessment document provided
Report findings and suggest path forward
Write and implement QMS