Comprehensive GMP Qualification & Validation Solution
QBridge Pharma provides end-to-end Qualification and Validation services to ensure pharmaceutical facilities, equipment, utilities and processes comply with global regulatory requirements. Our services are designed to support inspection readiness, data integrity and sustainable GMP compliance.
We follow a risk-based and regulatory-driven approach aligned with WHO-GMP, EU-GMP, PICs and international guidelines.
Comprehensive Qualification & Validation Services
Ensuring GMP compliance through a structured, risk-based and inspection-ready validation approach.
Risk Assessment
Identification of critical systems, equipment and processes impacting product quality and compliance.
URS & DQ
Preparation of User Requirement Specifications and Design Qualification aligned with intended use.
FAT & SAT
Factory and Site Acceptance Testing to verify system performance before installation and use.
IQ & OQ
Installation and Operational Qualification ensuring equipment is installed and operates as designed.
Performance
Verification of consistent and reproducible performance under routine operating conditions.
Documentation
Preparation of complete documentations to ensuring data integrity.
Equipment & Instrument Qualification
We provide qualification services for critical manufacturing and support equipment including:
- Manufacturing equipment qualification
- Laboratory instruments qualification
- Temperature mapping (Area & Equipment mapping)
- Utility systems qualification
- Calibration policy development & execution
Process Validation
Our team supports robust process validation to ensure consistent product quality and regulatory compliance.
- Validation strategy as per Annexure-15
- Risk-based validation approach
- Process validation protocol & report preparation
- Continued process verification (CPV) support
Cleaning Validation
We design and execute scientifically justified cleaning validation programs.
- Cleaning validation protocol & reports
- PDE-based limit calculations
- Worst-case product selection
- Swab & rinse sampling strategies
- DEHT & CEHT validation approach
- Room cleaning validation concepts
Sterile Facility Validation
Specialized validation support for sterile and aseptic facilities:
- Media fill validation
- Personnel validation
- Autoclave validation
Facility & Area Validation
- Facility Qualification
- Area classification & environmental monitoring support
- Cleanroom Qualification
- Area & HVAC validation as per ISO / EU guidelines
- Differential pressure, temperature & RH mapping
Ensure GMP Compliance Through Expert Validation
Partner with QBridge Pharma for reliable qualification and validation services aligned with global regulatory expectations.