Cold Chain Confidence: Validation Support for Biopharma Distribution
Cold Chain Package Validation, Cold Chain Transport, & Time Compression
Client Needs
A biopharmaceutical company needs assistance for preparing for NDA and PAI for a product packaged in vial with recommended storage temperature between 2-8C.
The Challenge
- Mapped supply chain routes to display product flow from the manufacturing site to point of administration using a process flow diagram
- Conducted a Risk Assessment (FMEA) on packaging and distribution network identifying potential risks. All risks for each step (e.g. packout, shipping receiving, and refurbishment/reuse) are noted in VMP
- Compiled VMP for packaging and distribution to determine the content of DQ and OQ. The VMP included responsibilities, the approach, identified risks and GDP requirements
- Modified User Requirements Specification that included secondary packaging and labelling design review to optimize packaging selection • Adept selected a suitable pre-qualified and standard shipping system with refurbishment option that reduces freight cost
- OQ and PQ protocols are generated, tests are executed, reports are written in a manner compliant with the client’s validation procedures
- Completed a VMP summary report for US filing. The combination of OQ and PQ showed a distribution process that is well-integrated, maintained product stability and accurate temperature monitoring
Our Approach
- Compiled a Validation Master Plan for the distribution of the drug.
- Optimized secondary and tertiary packaging.
- Design, define, select, and qualify distribution packaging.
- Performed simulated distribution studies for DQ OQ.
- Assisted in Execution and write Performance (PQ) protocols.
- Finalized the transport Validation Master Plan with the results of OQ and PQ.
The Impact
- Verified the ability of packaging system to safely protect the product
- Assisted in meeting the NDA filling deadline
- Met regulatory and internal requirements
Value to Client
Adept enabled the successful NDA filing for a temperature-sensitive biopharmaceutical product by delivering a fully compliant Validation Master Plan (VMP), optimizing the packaging system, and validating cold chain performance across the entire distribution process.
By conducting risk assessments, selecting a cost-efficient shipping system, and executing DQ, OQ, and PQ protocols, Adept ensured regulatory readiness, maintained product stability, and reduced freight costs—all while meeting tight filing deadlines.
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Want to reduce production costs, increase throughput, or optimize your packaging line? Let’s connect.