Temperature-Sensitive Supply Chain Assessments

Sensitech^® provides comprehensive temperature-sensitive supply chain assessments documenting internal and external practices of an organization as they relate to storage, handling, and distribution of medicinal products. Assessments are specifically designed to address unique customer needs and can be comprehensive, evaluating global supply chains over multiple seasons, or tailored to evaluate a specific trade lane, product, or other variable. Often, a program will evaluate practices and Standard Operating Procedures (SOPs) of logistics service providers, contract manufacturers, warehousing, (pick, pack, ship operations), distributors, wholesalers, re-packagers, as well as, internal operational sites – all with a focus on overall thermal compliance.

In addition to this review, Sensitech can perform a gap analysis documenting compliance against Current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP)/(GXP) as well as, Parenteral Drug Association (PDA) and U.S. Pharmacopeia (USP) standards, such as PDA TR 39 and USP <1079>. The information gathered during an assessment and the resulting analysis can be designed to satisfy internal quality and external regulatory expectations.

Sensitech’s Temperature-Sensitive Supply Chain Assessment is typically approached in a three-phase process.

Phase 1 – Assessment and Gap Analysis
The Assessment and Gap Analysis determines the current state of the supply chain and identifies areas requiring additional study, remediation, or both. During the assessment phase, Sensitech examines the following:

• Training Practices and Associated Documentation

• Review of Quality Agreements and Relevant Performance Metrics

• Thermal Monitoring Practices and Overall Performance

This examination results in a thorough gap analysis where Sensitech identifies and documents potential areas for improvement.

Phase 2 – Train, Implement, and Measure
The scope of phase 2 is defined by the analysis in phase 1. The Train, Implement, and Measure phase is intended to close any gaps identified during phage 1. This stage typically results in a proposal to qualify areas of potential concern, revise SOPs, and provide training as necessary.

Phase 3 – Continuous Monitoring
Continuous monitoring assures your organization that the steps taken in phase 2 were successful and helps to maintain high levels of quality and SOP compliance. During this phase, specific cold chain performance reports are often defined based on customer needs. These reports can be delivered through on-going monitoring programs.