ShockWatch Cold Chain Services Portfolio Overview

Cold Chain Consulting Portfolio Temperature Mapping Gap Analysis Validation Services Package Design Shipping Studies Product Calibration Cold Chain Services

Regulatory Compliance Gap Analysis Can address the full range of regulatory / accreditation requirements for an organization’s cold chain Documents the appropriate regulations and guidelines to which an organization must comply Identifies any deficiencies and can develop a remediation plan for addressing the deficiencies Overall areas that can be addressed include: ■ Regulatory gap analysis ■ Validation master plans ■ Remediation plans ■ CAPA programs ■ Risk analyses ■ Review & development of standard operating procedures (SOPs) ■ Staff training

Transport Qualification & Validation Services Show how the transport system, operations and processes are performed according to predetermined specifications and criteria. Provides experience and value-added knowledge around cGMP and GDP compliance and regulatory inspections for trailer qualification and transport validation for controlled- environment logistics worldwide

Package Design and Testing Identify and design an optimum packaging solution for protecting temperature sensitive products Ensure packaging is cost effective and compliant regulatory requirements Test and qualify existing cold chain packaging or design new cold chain packaging Confirm packaging complies with cold chain requirements Works with companies to perform regulatory qualifications ■ Component specification (CS) ■ Design testing (DT) ■ Operational qualification (OQ) ■ Performance qualification (PQ)

Shipping Studies Document the environmental hazards to which products may be exposed inside a distribution system. Creation of ambient profiles that accurately reflect the conditions a product may be exposed to assist in identifying appropriate logistics partners and transportation modes Temperature data is collected throughout the distribution system and under a variety of conditions Data analysis, development of relevant profiles and preparation of all regulatory documentation is included

Temperature Mapping Studies Objective of a temperature mapping is to document temperatures within defined areas where temperature sensitive products are shipped or stored. Examples of areas to be mapped: ■ Refrigerators ■ Transport trailers ■ Warehouses Follow a proven methodology: ■ Protocols are written and pre-approved ■ NIST traceable loggers are provided ■ Comprehensive documentation of temperature conditions during the study are provided, hot and cold spots identified ■ On-going monitoring requirements addressed ■ Opportunities for improvement identified

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