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Pharmaceutical third-party logistics providers (3PLs) must validate that their environments, systems, and processes maintain the required temperature, humidity, and operational controls to safeguard product quality. Performance Validation (PV) supports FDA-registered 3PLs by delivering comprehensive, regulatory-compliant validation services across all critical systems involved in the storage, handling, and transportation of temperature-sensitive pharmaceutical products. From warehouses and transportation units to digital systems and facilities, we ensure each system operates within defined parameters to protect product integrity and meet regulatory requirements.
PV’s Proven Validation Process for Pharmaceutical 3PLs
We follow a systematic, end-to-end process designed to help pharmaceutical 3PLs. From initial assessment to ongoing support, we ensure every system meets regulatory expectations and is fully documented for audit readiness.
Here’s our general process for most systems:
- Discovery & Assessment
- Site and system walkthrough/evaluation
- Regulatory gap assessment
- Identification of validation needs
- Planning & Protocol Development
- Plan development (VMP, CQMP, etc.)
- Creation of risk assessments, protocols, and test plans
- Execution
- On-site execution of IQ/OQ/PQ protocols and alternative delivery methods (remote support)
- Temperature mapping studies for warehouses, refrigerators/freezers, incubators/stability chambers, storage containers, vehicles, etc.
- Data collection and real-time troubleshooting as applicable
- Documentation & Reporting
- Final reports/summaries
- Preparation for audit or regulatory review
- Ongoing Support
- Requalification strategies
- Monitoring system validation
- Change control and system lifecycle management
Validation Services Built for Pharmaceutical 3PLs
Performance Validation understands the unique challenges pharmaceutical 3PLs face. That’s why we offer tailored validation services that cover everything from equipment qualification to digital system validation and temperature control. Our team works closely with you to ensure compliance with regulations while keeping your operations running smoothly.
Commissioning, Qualification, & Validation (CQV)
Our experts deliver end-to-end qualification of systems and equipment used in temperature-sensitive logistics:
- Refrigeration units and freezers
- Controlled room temperature (CRT) spaces
- Incubators and stability chambers
- Environmental monitoring systems (EMS)
- Packaging and distribution equipment
- Automated storage/retrieval systems (ASRS)
Computer System Validation (CSV)
PV ensures your digital systems operate reliably and meet regulatory expectations. Some examples of the systems we validate include:
- Electronic quality management systems (eQMS)
- Warehouse management systems (WMS)
- Temperature monitoring platforms and data sensors
- Electronic recordkeeping systems
- Environmental monitoring systems
Temperature Mapping
Pharmaceutical 3PLs must maintain strict control over temperature-sensitive products through storage, distribution, and packaging. With our help, you can meet the rigorous monitoring and validation protocols required by regulatory bodies, including the:
- U.S. Food and Drug Administration (FDA)
- World Health Organization (WHO)
- United States Pharmacopeia (USP)
- International Society for Pharmaceutical Engineering (ISPE)
- European Medicines Agency (EMA)
- Drug Supply Chain Security Act (DSCSA)
PV delivers expert temperature mapping services that confirm temperature uniformity across warehouses, transport vehicles, and packing configurations. From initial studies to routine requalification and ongoing monitoring strategies, PV ensures every mapping effort is executed correctly, thoroughly documented, and fully compliant. Our goal is to help 3PLs maintain compliance while minimizing operational disruptions.
Consulting
Whether you’re building a new facility or optimizing current operations, rely on us to provide:
- System and facility design reviews
- User Requirements Specification (URS) development
- Vendor and technology selection
- Validation master plan (VMP) development
- SOP and protocol creation
Building Commissioning (Cx)
PV ensures your facility is functional, efficient, and compliant for temperature-controlled processes from day one. Count on us for high-quality building commissioning services, including:
- HVAC and refrigeration system verification
- Building automation and EMS integration
- Alarm and backup system testing
- Full commissioning documentation
Why PV?
PV brings a unique combination of cold chain specialization, technical depth, and logistical flexibility to every pharmaceutical 3PL engagement. Here’s what makes our approach stand out:
- Cold Chain Expertise: Our team has decades of experience supporting temperature-sensitive logistics in regulated environments.
- Operational Flexibility: We work around your schedule to reduce downtime and accelerate project timelines without disrupting day-to-day operations.
- In-House Inventory: Our large stock of validated and calibrated temperature mapping equipment enables parallel execution across multiple areas, shortening project durations.
- Scalable Resources: With nationwide coverage and deep technical expertise, our team can rapidly deploy and adapt to meet project demands.
- Proven Project Management: We apply structured project management methodologies to deliver every project on time, on budget, and with consistently high quality.
Our approach is tailored to help 3PLs maintain compliance, minimize disruption, and move faster with confidence.
Trained to Support Pharmaceutical 3PLs at Every Turn
PV engineers are specifically trained to handle the complex needs of pharmaceutical 3PLs. Our expertise includes:
- Understanding regulatory expectations for pharmaceutical storage and transportation (FDA, USP, WHO, ISPE)
- Applying risk-based validation principles to optimize compliance and efficiency
- Operating advanced temperature mapping instrumentation and software
- Writing and executing validation protocols with precision
- Communicating effectively with clients and supporting regulatory audits
- Utilizing paperless validation to streamline documentation and improve traceability
With this training, PV engineers are fully equipped to help 3PLs achieve compliance while minimizing disruption and maximizing operational value.
Ready to Strengthen Your 3PL Validation Strategy?
At Performance Validation, we build long-term partnerships with pharmaceutical 3PLs to ensure every system, process, and facility is optimized for compliance. We understand the pressures you face, from evolving regulations to operational timelines. Let’s talk about your next project and how we can help move it forward.
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