Precision-Driven GMP Lab Installations Tailored for Regulatory Success

At International Process Solutions, we specialize in the planning, design, and execution of GMP-compliant laboratory installations that meet the stringent demands of pharmaceutical, biotechnology, and life sciences industries. Our expert team ensures each installation adheres to FDA, EMA, and ICH Q7 guidelines, laying the groundwork for operational integrity and regulatory assurance.

We collaborate directly with quality assurance teams, validation engineers, and facility managers to map out every detail of the lab setup—from environmental control systems to equipment layout—ensuring full traceability and workflow optimization. Whether it’s a cleanroom-certified microbiological lab or a complex analytical chemistry suite, we execute installations that support precision, safety, and audit readiness from day one.

GMP Equipment Calibration Services for Maximum Accuracy and Compliance

We provide comprehensive calibration services tailored to the critical equipment used in regulated laboratory environments. All calibrations are traceable to NIST standards and documented meticulously to meet 21 CFR Part 11 electronic records compliance.

Our calibration coverage includes:

• Analytical balances and scales
• pH meters and conductivity meters
• Temperature mapping and data loggers
• Autoclaves and sterilizers
• Pressure gauges and transmitters
• Spectrophotometers and HPLC systems

Each calibration is delivered with a detailed Certificate of Calibration, including “as found” and “as left” data, uncertainty values, and reference standards. We also maintain client calibration schedules and provide on-site or depot calibration services depending on operational needs.

Cleanroom-Ready Instrumentation Setup and Validation

Our team ensures all instruments installed in GMP cleanrooms are properly classified, installed, and qualified under validated procedures. We work within ISO 14644 and cGMP requirements to deliver turnkey cleanroom setups that include air particle counters, temperature and humidity sensors, HEPA filtration monitors, and automated environmental controls.

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols are developed in-house and tailored to your SOPs and equipment specifications. Each phase is executed under a GAMP 5 framework, reducing risk and ensuring repeatable, auditable outcomes.

Turnkey Solutions for New GMP Laboratories and Facility Expansions

From greenfield facilities to lab expansions, we manage the full lifecycle of lab installation, from design concept to commissioning and validation. Our multidisciplinary team includes architects, engineers, project managers, and GMP consultants who bring deep domain expertise to every phase.

Key capabilities include:

• Lab layout optimization for unidirectional flow and contamination control
• Utility integration for WFI, compressed air, HVAC, and clean steam
• Process equipment selection and configuration
• Data integrity architecture for lab automation systems

We deploy a phased project execution model that aligns with your timeline, budget, and quality assurance goals. Our meticulous planning ensures every utility, workbench, and process instrument is GMP-ready and fully validated before handoff.

GMP Compliance Audits and Ongoing Support

After initial setup and calibration, we provide ongoing support and requalification services to ensure labs remain compliant as they evolve. Our GMP audit services assess your laboratory’s compliance with evolving regulatory expectations and industry best practices.

Support offerings include:

• Preventive maintenance and recalibration
• Gap analyses and deviation investigations
• SOP development and staff training
• Risk-based periodic reviews of equipment performance

We also offer emergency field services with rapid response times to address unexpected equipment failures or audit findings. Our regional support teams are strategically located to serve California, the Pacific Northwest, and beyond.

Digital Traceability and Calibration Asset Management

Utilizing 21 CFR Part 11-compliant software, we ensure complete traceability of all installations, calibrations, and validations. Our cloud-based asset management system allows clients to access real-time equipment status, service history, calibration certificates, and upcoming due dates from any secure device.

Clients benefit from:

• Automated reminders and calibration scheduling
• Custom dashboards for tracking compliance metrics
• Secure document repositories for audit preparation
• Remote troubleshooting support for select equipment

Industries Served

Our team has delivered GMP lab installations and calibration solutions for:

• Pharmaceutical manufacturers
• Biotechnology startups and scale-ups
• Medical device manufacturers
• Contract research and manufacturing organizations (CROs/CMOs)
• Veterinary pharmaceutical firms
• Nutraceutical and cosmetic testing laboratories

With every engagement, we bring unmatched attention to compliance, quality, and customer success.

Why Choose International Process Solutions

• GMP-specialized engineers and technicians
• In-house validation team
• Rapid turnaround times for calibration and qualification
• Customizable service contracts
• Proven track record with FDA-inspected facilities
• Partnerships with top-tier lab equipment manufacturers

We are more than a service provider—we are a trusted compliance partner dedicated to ensuring your lab operates at peak precision and maintains a flawless audit trail.

Contact Us for GMP Lab Installation and Calibration Excellence

Whether you’re building a brand-new GMP facility, expanding your lab operations, or seeking a reliable calibration partner, International Process Solutions delivers solutions designed for regulatory confidence and operational continuity.

Contact our team today to learn how our GMP lab installation and calibration services can support your mission-critical work and help you meet the highest standards of quality and performance.