Reine Lifescience — Quality Assurance & Quality Control

Precision Testing at Every Stage

Our QC laboratories operate under validated systems ensuring all raw materials, intermediates, and finished APIs meet predefined specifications before release — guaranteeing safety, efficacy, and consistency.

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    Raw Material, Intermediate & Finished Product Testing Complete analytical testing at every stage of production lifecycle
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    Analytical Method Development & Validation ICH-compliant methods developed and validated for accuracy & reproducibility
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    Stability Studies as per ICH Guidelines Long-term and accelerated stability programs per ICH Q1A–Q1F
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    Environmental Monitoring & Water Analysis Continuous monitoring of cleanroom environments and purified water systems
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    Reference Standards & Retention Sample Management Systematic archival and lifecycle management of all reference materials
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Chromatography
HPLC Analysis
High-Performance Liquid Chromatography for precise identification, quantification, and purity testing of APIs and impurities.
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Chromatography
GC & GC Headspace
Gas Chromatography and GC Headspace analysis for residual solvents, volatile impurities, and organic compound profiling per ICH Q3C.
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Spectroscopy
FTIR & UV-VIS Spectroscopy
Fourier Transform Infrared and UV-Visible spectroscopy for structural confirmation, identity testing, and quantitative absorbance analysis.
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Physical Analysis
Chemical Analytical Laboratory
Particle size analysis, bulk density, tapped density, and sieve shaker testing to ensure physical characteristics meet specifications.
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Microbiology
Microbiology Department
Microbial limit testing, bioburden analysis, sterility assurance, and environmental monitoring ensuring pharmaceutical-grade microbiological purity.

Our Quality Pillars

Built on a foundation of regulatory excellence, analytical precision, and a culture of continuous improvement

01
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Global cGMP Compliance

Fully aligned with ICH, WHO-GMP, USFDA, EU-GMP, and pharmacopoeial standards (IP, BP, USP, EP) — ensuring seamless global market acceptance.

02
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Advanced Analytical Labs

State-of-the-art instrumentation including HPLC, GC, FTIR, UV-VIS, and stability chambers delivering high precision and validated results.

03
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Data Integrity & ALCOA+

Strict adherence to ALCOA+ principles — ensuring all data is attributable, legible, contemporaneous, original, accurate, and audit-ready.

100% Batch Release Compliance

Committed to Quality
in Every Batch Released

Each batch undergoes rigorous in-process and final quality evaluation before release. Our Quality Unit ensures complete documentation review, deviation control, and compliance verification — guaranteeing only products meeting predefined specifications reach our partners.

Built on Validated Systems

Our QC laboratories ensure all raw materials, intermediates, and finished APIs meet predefined specifications before release — ensuring safety, efficacy, and consistency.

  • Raw Material, Intermediate & Finished Product Testing
  • Analytical Method Development & Validation
  • Stability Studies as per ICH Guidelines
  • Environmental Monitoring & Water Analysis
  • Reference Standards & Retention Sample Management

Quality Control

Our Quality Control laboratories operate under validated systems to ensure that all raw materials, intermediates, and finished APIs meet predefined specifications before release — ensuring safety, efficacy, and consistency.

100%
Batch Compliance
5+
Validated Methods
ICH
Guideline Aligned
24/7
Lab Operations

World-Class Testing Infrastructure

Each department is equipped with validated, state-of-the-art instruments ensuring precise, reproducible, and globally compliant analytical results

HPLC Lab
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HPLC Video

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🔬 Chromatography

HPLC — High Performance Liquid Chromatography

Our HPLC laboratory is the backbone of API identification and purity profiling. Equipped with cutting-edge systems, we achieve precise quantification of active ingredients, related substances, and degradation products to pharmacopoeial and ICH standards.

  • Assay and purity testing for all API batches
  • Related substances and impurity profiling
  • Validated methods per USP, BP, EP, IP
  • System suitability testing on every run
  • Dissolution testing for formulation support
GC Lab
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GC / GC Headspace Video

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⚗️ Gas Chromatography

GC & GC Headspace Analysis

Our Gas Chromatography and GC Headspace systems are dedicated to residual solvent testing and volatile impurity detection. Fully compliant with ICH Q3C guidelines, these systems safeguard API quality at the molecular level.

  • Residual solvent testing per ICH Q3C
  • GC Headspace for Class I, II & III solvents
  • Volatile organic compound (VOC) profiling
  • Quantitative analysis with FID and ECD detectors
  • Method validation and LOD/LOQ determination
Spectroscopy
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FTIR / UV-VIS Video

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💡 Spectroscopy

Spectroscopy — FTIR & UV-VIS

Fourier Transform Infrared (FTIR) and UV-Visible spectroscopy form our identity confirmation and quantitative analysis powerhouse — providing rapid, non-destructive structural fingerprinting of every API batch.

  • FTIR for structural identity and polymorphic characterisation
  • UV-VIS for quantitative absorbance measurement
  • Water content determination by KF titration
  • Colour and clarity measurement
  • Spectral library matching for rapid ID
Chemical Lab
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Chemical Analytical Lab Video

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🧪 Physical Analysis

Chemical Analytical Laboratory

Our Chemical Analytical Lab specialises in physical property characterisation — ensuring APIs meet stringent particle size, density, and flowability specifications critical for downstream formulation success.

  • Particle size distribution analysis
  • Bulk density and tapped density determination
  • Sieve shaker analysis for granulometry
  • Loss on drying (LOD) and moisture content
  • pH, specific gravity and optical rotation
Microbiology
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Microbiology Department Video

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🦠 Microbiology

Microbiology Department

Our dedicated Microbiology Department operates in a controlled cleanroom environment, ensuring every API batch is free from microbial contamination and meets the highest standards of pharmaceutical purity and sterility assurance.

  • Total microbial count (TAMC & TYMC)
  • Bioburden testing and trend analysis
  • Environmental monitoring program
  • Purified water and WFI microbial testing
  • Identification of specified organisms (E. coli, Salmonella, etc.)

Quality Built Into Every Process

Our QA system proactively ensures compliance, risk mitigation, and continuous improvement at every stage of manufacturing

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Robust Quality Management System

A comprehensive QMS governing all manufacturing operations, documentation, training, and continuous improvement activities aligned with global cGMP requirements.

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Deviation Handling, Change Control & CAPA

Systematic management of deviations, change control workflows, and corrective/preventive action systems ensuring quality events are resolved and prevented.

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Internal Audits & Regulatory Readiness

Regular internal audit programs and mock inspections ensure we remain perpetually inspection-ready for WHO, MFDS, EDQM, and other regulatory authorities.

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Vendor Qualification & Material Traceability

Rigorous supplier qualification processes and end-to-end material traceability systems ensuring the integrity and compliance of every incoming component.

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Training Programs & Compliance Culture

Ongoing GMP training, competency assessments, and a culture of quality ownership ensure every team member contributes to maintaining the highest standards of pharmaceutical excellence — from laboratory bench to batch release documentation.

Global Certifications & Regulatory Approvals

Our facilities and quality systems are recognised by international regulatory authorities, reflecting our commitment to compliance, transparency, and global market readiness

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ISO 9001:2015
Quality Management
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WHO-GMP
Global Manufacturing
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KOREA MFDS
Korean Regulatory
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EDQM
European Quality
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ICH Guidelines
Harmonised Standards
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ISO 17025
Lab Competence