CLEEN Go-Live at Amneal
Amneal Pharmaceuticals goes live with Leucine's CLEEN — Cleaning Validation Software at their Palli facility in Ahmedabad.
“From ensuring regulatory-compliant risk-driven procedures to real-time audit readiness, the CLEEN application empowers pharma companies to ensure accurate HBEL-based residue limit calculations, track real-time validation status for all equipment, and accelerate new drug introduction through instant risk assessments.”
Leucine
CLEEN Go-Live at Amneal Pharmaceuticals, 2026
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About the Event
Amneal Pharmaceuticals, one of the largest generic pharmaceutical manufacturers in the United States, successfully went live with Leucine's CLEEN — Cleaning Validation Software at their Palli manufacturing facility in Ahmedabad, India on February 10, 2026.
The go-live marks the digitisation of Amneal's entire cleaning validation lifecycle — from protocol design and residue calculations to risk assessments and regulatory reporting — into a single connected platform with real-time visibility, automated compliance, and audit-ready documentation.
The go-live event included addresses from Amneal leadership, a presentation by Leucine, a felicitation ceremony recognising the implementation team, and a cake-cutting ceremony to mark the milestone.
Key Themes
- ↪ HBEL-based residue limit calculations with full traceability
- ↪ Real-time validation status tracking for all equipment
- ↪ Accelerated new drug introduction through instant risk assessments
- ↪ Regulatory-compliant risk-driven procedures and audit readiness
CLEEN
Product Deployed
Palli
Facility Location
100%
Digital Cleaning Validation
Day 1
Audit-Ready
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Leucine &
the Go-Live
Leucine partnered with Amneal's quality and validation teams to deploy CLEEN at the Palli facility — replacing manual cleaning validation workflows with a fully digital, compliance-ready platform.
The go-live event was held on-site at Amneal's Palli facility, with presentations from both Amneal leadership and Leucine, followed by a felicitation ceremony recognising the team members who drove the implementation to completion.
Nobel Philip from Leucine addressed the audience, highlighting how CLEEN enables pharma manufacturers to move from reactive, paper-based cleaning validation to proactive, risk-driven digital workflows — with every calculation, decision, and approval captured in a compliant audit trail.
What We Showcased
CLEEN
Automated cleaning validation with HBEL calculations, worst-case matrix generation, and protocol auto-generation.
Residue Limit Calculations
Accurate HBEL-based residue limit calculations with full traceability and audit trail.
Equipment Validation Tracking
Real-time validation status for all equipment — instant visibility into cleaning compliance.
Risk Assessments
Instant risk assessments to accelerate new drug introduction and product changeovers.
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Speakers &
Panels
Digambar Nigade
Welcome Address
Amneal Pharmaceuticals
Dr. Sanjay Jain
Leadership Address
Amneal Pharmaceuticals
Partha Maity
Address by Amneal
Amneal Pharmaceuticals
Nobel Philip
Address by Leucine
Leucine
Prakash Prajapati
Felicitation Ceremony
Amneal Pharmaceuticals
Powered by
Leucine CLEEN
The cleaning validation platform that powers Amneal's digital cleaning validation lifecycle — from HBEL-based residue calculations and worst-case matrix generation to real-time equipment validation tracking and audit-ready documentation.
Explore Leucine CLEEN04 /
Key Takeaways
Amneal's Palli facility now runs a fully digital cleaning validation lifecycle — from protocol design to regulatory reporting — with zero manual calculations.
HBEL-based residue limit calculations are automated with full traceability, eliminating manual calculation errors and reducing validation cycle times.
Real-time equipment validation status gives quality teams instant visibility into cleaning compliance across the facility.
New drug introductions are accelerated through instant risk assessments — no more weeks of manual worst-case matrix generation.
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Photos
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Get in touch
See It
in Action
Interested in what Leucine demonstrated at Amneal Pharmaceuticals Goes Live with CLEEN? Our team can walk you through the platform and discuss how it applies to your manufacturing operations.