Corporate Quality & GMP Policy
LEP India Cosmetics Pvt. Ltd. is committed to engineering and manufacturing premium skincare, haircare, baby care, and personal hygiene products that consistently satisfy the highest international standards of safety, efficacy, purity, and regulatory compliance. Our 6,000 Sq Ft facility operates under rigorous Good Manufacturing Practices (cGMP) aligned with ISO 22716:2007 and US FDA cosmetics regulations.
1 Facility Infrastructure & Cleanroom Environments
Cosmetic compounding and automated filling operations are housed within isolated, positively pressurized cleanrooms designed to prevent airborne particulate contamination:
Centralized AHU systems equipped with 0.3-micron HEPA filtration, maintaining temperature (21°C ± 2°C) and relative humidity control (50% ± 5%).
Dynamic interlocking personnel airlocks, sticky floor mats, and UV pass-through boxes ensure zero cross-contamination between dirty and clean zones.
Seamless, anti-microbial coved epoxy flooring with no 90-degree corners to facilitate complete medical-grade daily sterilization.
2 Pharmaceutical-Grade Water Treatment (RO + DM System)
Because water is the foundation of superior cosmetic emulsions and active serums, our plant operates a dedicated, multi-stage water treatment facility:
- Multi-Stage Filtration: Sand filtration, activated carbon absorption, twin-bed demineralizers (DM), and double-pass Reverse Osmosis (RO).
- Continuous UV & Endotoxin Sterilization: Closed-loop 316L stainless steel circulation loop with continuous UV disinfection and 0.2-micron microbial post-filters.
- Daily Conductivity & Microbial Testing: Daily bench testing for electrical conductivity (< 1.3 µS/cm), Total Dissolved Solids (TDS < 5 ppm), and zero viable coliform count.
3 Raw Material Vendor Audit & Quarantine Protocols
We exclusively procure botanical extracts, active cosmeceuticals, functional polymers, and essential oils from certified, audited global suppliers (BASF, Croda, Clariant, Evonik, Givaudan, Symrise, DSM):
4 Batch Manufacturing Records (BMR) & Digital Traceability
Every compounding batch is executed under an official Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) signed off by senior production chemists:
- Complete Dual-Directional Traceability: We can trace any finished cosmetic bottle back to its exact active ingredient lot number, blending operator, homogenization speed, temperature cycle, and packaging date.
- SS 316L Reactors: Compounding is carried out in sanitary-grade SS 316L jacketed vacuum homogenizers featuring planetary scraped surface agitators and high-shear bottom emulsifiers.
- CIP/SIP Cleaning: Automated Clean-In-Place (CIP) and Steam-In-Place (SIP) cycles sanitize tanks, pipes, and filling nozzles between fragrance and formula transitions.
5 In-Process Quality Checks (IPQC) & Line Clearance
Throughout compounding, filling, and final packing, dedicated QC inspectors conduct hourly line audits:
Real-time verification of pH value, Brookfield viscosity, specific gravity, refractive index, and color matching against approved master control samples.
Vacuum chamber leak testing for bottles and pump crimping, torque testing on closures, induction heat seal checks, and barcode scannability verification.
Mandatory visual inspection and line clearance authorization before changing over packaging components to eliminate label mix-ups.
6 Finished Product Testing, Release & Retention Archiving
No product leaves the factory warehouse without an authorized Quality Release Certificate:
- Comprehensive Microbial Quarantine: 48 to 72 hour incubation screening for Total Aerobic Microbial Count (TAMC) and Total Yeast & Mold Count (TYMC) per USP 61/62 standards.
- Stability Chambers: Accelerated stability testing (40°C / 75% RH) and real-time shelf life monitoring in calibrated environmental chambers (ICH Guidelines).
- Control Archive: Physical control samples of every finished batch are sealed and preserved in our climate-controlled sample bank for 36 months post-manufacturing.
7 Certifications, Statutory Licensing & Export Readiness
LEP India Cosmetics Pvt. Ltd. operates under statutory manufacturing licenses and international quality compliance accreditations:
Request Quality Audits & Regulatory Documentation
Our Quality Assurance and Regulatory Affairs team provides full validation packages, standard operating procedures (SOPs), and site master files for corporate client audits.
