At Leobery Pharmaceutical Industries LLC, quality is not just a process — it is our culture. Every product we manufacture follows strict international regulatory standards to ensure safety, efficacy, consistency, and reliability.
Our quality system covers the full product lifecycle:
R&D → Raw Material Sourcing → Manufacturing → Packaging → Storage → Distribution → Post-Marketing Surveillance
⸻
🔒 Quality Management System (QMS)
Our Quality Management System is aligned with:
• WHO-GMP (World Health Organization – Good Manufacturing Practices)
• ISO 9001:2015 Quality Standards
• cGMP guidelines (Current Good Manufacturing Practice)
• ICH Q7, Q8, Q9, Q10 international guidelines
• Local regulatory requirements (CDSCO, FDA, MHRA, EU guidelines depending on region)
Our QMS ensures:
✔ Documented SOPs
✔ Trained technical staff
✔ Preventive & corrective actions (CAPA)
✔ Deviations & change control
✔ Continuous quality improvement
✔ Batch traceability up to final distribution
⸻
🧪 Raw Material Quality Control
We only source pharmacopeia-grade raw materials (IP/USP/BP/EP) from approved vendors.
Every raw material undergoes:
• Identity testing
• Purity assessment
• Microbial evaluation
• Heavy metals & impurity profiling
• Certificate of Analysis (CoA) verification
No material is accepted without QC approval.
⸻
🏭 Manufacturing Excellence
Our manufacturing units follow high-standard production practices:
✔ Controlled manufacturing areas
• Class 100,000 (ISO 8) clean rooms
• Hygienic environment with HEPA filtration
• Temperature & humidity controlled zones
✔ Modern production technology
• Automatic syrup lines
• High-speed tablet compression machines
• Clean-in-Place (CIP) & Sterilize-in-Place (SIP) systems
• Blister and bottle packaging lines
• In-house label & QR authentication systems
✔ Calibration & validation
• Equipment qualification (IQ/OQ/PQ)
• Process validation & cleaning validation
• Analytical method validation
⸻
🔍 Quality Control (QC) Laboratory
Our QC labs are equipped with:
• HPLC
• UV Spectrophotometer
• Dissolution testers
• Stability chambers (ICH compliant)
• Microbiology lab for sterility & endotoxin tests
QC performs:
✔ Assay & content uniformity
✔ Dissolution & disintegration
✔ Microbial limit tests
✔ Stability testing (accelerated & real-time)
Each batch is released only after QC certification.
⸻
📦 Packaging & Serialization
Every product is packaged in a controlled setting with:
• Barcoding / QR code for anti-counterfeiting
• Tamper-proof packaging
• Batch number, Mfg/Exp date, unique ID
• High-strength blister & bottle materials
Serialization ensures end-to-end product traceability.
⸻
🚚 Supply Chain Quality
Our logistics follow proper distribution practices:
• GDP (Good Distribution Practices) certified
• Cold chain maintenance (where required)
• Temperature monitoring through the supply route
• Verified transport partners
⸻
👨⚕️ Regulatory & Compliance
Our regulatory team handles:
• CTD/eCTD dossier preparation
• Global product registrations
• Stability & bioequivalence data
• Artwork and labeling compliance
• Pharmacovigilance & PMS reporting
We are committed to complete transparency with regulatory authorities worldwide.
⸻
🛡️ Pharmacovigilance — Patient Safety First
Our pharmacovigilance system includes:
• Adverse event reporting
• Risk management plans
• Periodic safety update reporting (PSUR)
• Post-marketing surveillance
This ensures each product remains safe throughout its lifecycle.
⸻
🌍 Why Our Manufacturing Stands Apart
• WHO-GMP Compliance
• Global regulatory adherence
• Experienced technical team
• Advanced QC/QA infrastructure
• Strong supply chain controls
• Focus on safety & consistency
• End-to-end traceability
