Case Study — Pharmaceuticals & Cold Chain
Case Study: GDP-Compliant Cold Chain for India’s Largest API Exporter
How SSL delivered GDP-compliant cold chain for India’s largest API exporter — zero excursions, EU audit passed, 847 shipments. SSL pharma logistics case study.
The Challenge
A Hyderabad-based API manufacturer exporting to 18 countries needed GDP-compliant cold chain for temperature-sensitive APIs (2°C–8°C) from their Hyderabad plant to JNPT for ocean export and to Hyderabad Rajiv Gandhi International Airport for air freight. Their previous logistics provider had failed a regulatory audit by a European health authority — with temperature excursions documented in 4 of 12 sampled shipments. The manufacturer was at risk of losing their European market certification.
The SSL Solution
SSL’s pharma cold chain team conducted a 6-week qualification process: vehicle temperature mapping validation studies for all assigned reefer units, driver training certification specifically for pharma GDP protocols, SOP documentation to EU GMP standards, control tower system audit with 24/7 monitoring capability, and a mock audit run through SSL’s complete documentation package. SSL was then assigned as the exclusive cold chain provider for all this manufacturer’s EXIM cold chain from Hyderabad — covering 2°C–8°C API transport, 15°C–25°C finished dosage, and -18°C frozen biological products.
Outcome
After 24 months: Zero temperature excursions across 847 API shipments. The manufacturer successfully passed the European health authority re-audit with SSL’s temperature logs and documentation package forming part of the quality dossier. The client’s European market certification was maintained and subsequently expanded to 3 additional EU country certifications. SSL’s documentation discipline — GPS audit trail, 15-minute temperature logs, complete chain of custody — was cited by the regulatory auditor as ‘exemplary’ in the audit report. The client has since expanded SSL’s scope to include finished dosage cold chain for their domestic distribution.
Why SSL Won This Engagement
SSL’s GDP qualification process was more rigorous than the client’s previous logistics provider — but also more rigorous than any of the other alternatives evaluated. SSL is one of very few Indian logistics companies whose cold chain documentation package can withstand EU GMP regulatory scrutiny. This is not a certification — it is operational discipline built through years of pharmaceutical cold chain service. The manufacturer ultimately chose SSL because our qualification process demonstrated operational maturity that matched the seriousness of their regulatory exposure.
Questions About This Case
How did SSL solve Pharmaceuticals & Cold Chain logistics challenges?
SSL’s pharma cold chain team conducted a 6-week qualification process: vehicle temperature mapping validation studies for all assigned reefer units, driver training certification specifically for phar… Contact SSL for a full case study discussion.
Can SSL do this for my company?
Yes. SSL has replicated similar solutions across 100+ enterprise clients. Contact corporatesales@sslpl.in or call +91-92978-78787 for a customised assessment within 48 hours.
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