At NCQC Laboratory LLP, we provide end-to-end Validation Services designed to ensure that facilities, systems, analytical methods, processes, utilities and equipment consistently deliver results that meet predetermined specifications and regulatory requirements.
Validation is a critical component in pharmaceutical, healthcare, and industrial environments, ensuring product quality, safety, and compliance with global standards such as GMP, ISO, and regulatory guidelines. Our team adopts a scientific and risk-based approach to validation, ensuring accuracy, reliability, and full compliance.
Processes, analytical methods, tests, facilities, utilities and equipment
Industries We Serve
- Pharmaceutical & Healthcare
- Biotechnology
- Food & Beverage
- Research Laboratories
- Hospitals & Cleanroom Facilities
Our Validation Services
HVAC Validation
We ensure that your HVAC systems maintain required environmental conditions for controlled areas.
Key Tests Include:
- Air Velocity Measurement
- Air Changes Per Hour (ACPH) Calculation
- HEPA Filter Integrity Test (PAO/DOP Test)
- Non-Viable Particle Count (NVPC)
- Recovery Test
- Airflow Visualization (Smoke Study)
Cleanroom Validation
We verify cleanroom performance as per ISO classification standards.
Scope Includes:
- Cleanroom classification (ISO Class)
- Particle count analysis
- Airflow pattern verification
- Pressure differential checks
Thermal / Temperature Mapping
We perform mapping studies to ensure uniform temperature distribution.
Applications:
- Warehouses
- Cold Rooms
- Stability Chambers
- Deep Freezers
- Incubators and Ovens
- Autoclaves
Mapping is performed using data loggers placed as per regulatory guidelines to identify hot and cold spots.
Utility Validation
We validate critical utilities required for production and laboratory operations.
Includes:
- Compressed Air Quality Testing
- Water System Validation
Why Choose NCQC for Validation Services
- Compliance with GMP, ISO, and regulatory standards
- Accurate and traceable measurement systems
- Detailed and audit-ready documentation
- In line with 21 CFR Part 11, annex 11 EU GMP, Data Integrity, ISO/ IEC 17025 and GMP standards
- Improved system reliability and product quality
- Identification of potential risks and deviations
- Skilled and experienced validation engineers
- Use of advanced and calibrated instruments
- Strong understanding of regulatory requirements
- Timely project execution
- Customer-focused and flexible solutions
Our Approach
We follow a systematic validation lifecycle approach that includes:
- Understanding user requirements
- Risk assessment and planning
- Execution using calibrated instruments
- Data analysis and reporting
- Documentation aligned with audit requirements
All activities are performed by trained professionals using traceable and calibrated equipment to ensure data integrity and reliability.