QC Laboratory Design & Setup

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QC Laboratory
Design & Setup

Designing, equipping and qualifying analytical and microbiology labs.

Quality Control laboratories are the gatekeepers of product safety and regulatory compliance. UDQS provides technical and practical support for the development of new labs and the upgrading of existing facilities to world-class standards.

Layout & Flow

  • Sample and personnel flow design
  • Segregation of clean/dirty activities
  • Cross-contamination prevention
  • Optimized lean lab workflows

Analytical Suite

  • HPLC, GC, & LC-MS/MS systems
  • FTIR, UV-Vis, & Dissolution
  • Equipment selection & procurement
  • Vendor design qualification (DQ)

Microbiology Lab

  • Autoclave & Media prep setup
  • Incubator & Stability chambers
  • Biosafety cabinets & Isolators
  • Environmental monitoring systems

Qualification (AIQ)

  • IQ/OQ/PQ of lab instruments
  • Utility (Water/Gas) integration
  • Computerized system validation
  • Calibration & maintenance plans

ISO/IEC 17025

  • Alignment with 17025 principles
  • Analytical method validation
  • Traceability & logbook design
  • Standard Operating Procedures

Data & LIMS

  • Data Integrity (ALCOA+) reviews
  • LIMS selection & integration
  • Electronic record management
  • Audit trail configuration

Integrated Laboratory Excellence

A compliant laboratory goes beyond high-end equipment. We ensure the scientific foundation—method validation, analyst competency, and data reliability—is robust enough to withstand stringent regulatory audits.

  • 01 Method Transfer & Verification
  • 02 Reference Standard Management
  • 03 Out-of-Specification (OOS) Training

Quality tested laboratory delivery for world-class results.

Let’s Build Your Path to
Regulatory Excellence.