Zydus Lifesciences + Leucine
Digitising and scaling cleaning validation across 7+ manufacturing facilities in India and the US with Leucine CLEEN.
“CLEEN transformed how we approach cleaning validation — what used to take weeks of manual calculations and paper-based protocols now runs in hours with full audit-readiness built in. Rolling it out across seven facilities was the proof that this scales.”
Senior Validation Leader
Zydus Lifesciences
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Challenge
Zydus Lifesciences is India's fourth-largest pharmaceutical company, operating 35 state-of-the-art manufacturing facilities across India, the United States, and Brazil. The company manufactures across the entire pharmaceutical value chain — formulations, APIs, vaccines, biosimilars, complex products, and wellness products — with 8 FDA-approved finished dosage sites and 2 FDA-approved API plants. Its products are sold in 55 countries and regulated by the USFDA, TGA, WHO, and Indian regulatory authorities.
Cleaning validation is one of the most critical and complex compliance requirements in pharmaceutical manufacturing. Every piece of shared equipment must be validated to ensure that residues from one product do not carry over into the next at levels that could affect patient safety. This requires calculating health-based exposure limits (HBELs), determining worst-case product and equipment combinations, generating validation protocols, executing cleaning studies, and maintaining ongoing verification — all with full documentation and audit trails.
Across Zydus's multi-site manufacturing network, cleaning validation was managed through a combination of spreadsheets, paper-based protocols, and manual calculations. Each facility maintained its own cleaning validation documentation independently. Residue limit calculations — which involve toxicological data, therapeutic doses, batch sizes, and equipment surface areas — were performed manually in spreadsheets, creating a persistent risk of calculation errors that could compromise both patient safety and regulatory standing.
The paper-based approach made it nearly impossible to maintain real-time visibility into validation status across facilities. When an FDA inspector asked for the current validation status of a specific equipment train or product changeover, the answer required hours of manual document retrieval. Worst-case matrices had to be rebuilt manually whenever a new product was introduced, and there was no systematic way to track whether cleaning procedures remained validated as product portfolios and equipment configurations evolved.
With regulatory expectations around cleaning validation tightening globally — particularly the shift toward HBEL-based limits and the increased scrutiny of shared equipment in multi-product facilities — Zydus needed a system that could not only digitise the existing process but fundamentally change the speed, accuracy, and scalability of cleaning validation across its network.
- ↪ How do you ensure residue limit calculations are accurate when they're done manually in spreadsheets across multiple sites?
- ↪ How do you maintain real-time visibility into validation status across 7+ facilities for FDA readiness?
- ↪ How do you rebuild worst-case matrices efficiently every time a new product is introduced?
- ↪ How do you scale cleaning validation consistently when each site manages documentation independently?
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Solution
Leucine CLEEN was deployed across Zydus's manufacturing network to digitise and automate the entire cleaning validation lifecycle — from residue limit calculations and worst-case analysis through protocol generation, execution tracking, and ongoing verification. The platform replaced the fragmented system of spreadsheets and paper-based protocols with a single, centralised system that every facility could use to the same standard.
The first and most immediate impact was on residue limit calculations. CLEEN's automated HBEL-based calculation engine replaced manual spreadsheet work — pulling in toxicological data, therapeutic doses, batch sizes, and shared equipment surface areas to compute permissible carryover limits automatically. This eliminated the calculation errors that are inherent in manual processes and ensured that every limit was computed consistently, regardless of which facility or which validation scientist performed the work.
Worst-case product and equipment combinations — one of the most time-consuming aspects of cleaning validation — were automated through CLEEN's matrix engine. When a new product is introduced to a facility, the system automatically recalculates the worst-case scenarios across all shared equipment, identifies which cleaning procedures need revalidation, and flags any gaps. What previously took days of manual analysis now happens in minutes.
For each validation study, CLEEN auto-generates protocols tailored to the specific products, equipment, and cleaning procedures involved — complete with sampling plans, acceptance criteria, and documentation requirements. These protocols are generated in an audit-ready format with full traceability, eliminating the hours previously spent manually assembling validation documents.
The rollout followed a phased facility-by-facility deployment across 7+ sites in India and the US. Each facility's product portfolio, equipment inventory, and cleaning procedures were configured in the platform. The Leucine team worked with Zydus's validation and quality teams at each site to migrate existing validation data, configure site-specific parameters, and train validation scientists on the new system.
With all facilities now on a single platform, Zydus's quality leadership has real-time visibility into cleaning validation status across the entire network through centralised dashboards. Validation scientists can see at a glance which equipment is validated, which studies are in progress, which products require revalidation, and where gaps exist — across every site, from a single interface. During regulatory inspections, the data is immediately accessible and audit-ready, replacing the hours of manual document retrieval that inspections previously required.
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Impact
7+
Manufacturing facilities running CLEEN across India and the US
80%
Faster cleaning validation cycle times through automation
100%
Elimination of manual calculation errors in residue limit computations
0
Paper-based cleaning validation protocols remaining in deployed facilities
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Leucine CLEEN
The cleaning validation platform that digitised and automated Zydus's entire validation lifecycle — from HBEL-based residue calculations to audit-ready protocol generation — across 7+ manufacturing facilities.
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