In the highly regulated pharmaceutical industry, precision and compliance are non-negotiable. At the core of pharmaceutical quality assurance lies accurate calibration services that ensure equipment meets stringent regulatory requirements, maintains product integrity, and guarantees patient safety. We specialize in comprehensive pharmaceutical calibration services, meticulously tailored to meet the rigorous standards of FDA, cGMP, and ISO 17025 compliance.
Why Calibration Matters in the Pharmaceutical Sector
The consequences of calibration errors in pharmaceutical operations can be severe—from regulatory penalties and product recalls to compromised patient safety. Precise calibration ensures:
- Equipment performance remains within allowable tolerances
- Data integrity for audit trails
- Consistent, reliable batch production
- Extended lifespan of critical instrumentation
Our end-to-end calibration services are designed to minimize risk, optimize operational efficiency, and maintain regulatory readiness at all times.
In-Lab and On-Site Calibration Solutions
We provide both in-lab and on-site calibration depending on the needs of your facility. Our mobile teams are equipped to perform high-accuracy calibrations across the full range of pharmaceutical instruments.
In-Lab Calibration
- Conducted in our climate-controlled laboratories
- Instruments are tested under optimal environmental conditions
- Suitable for high-precision equipment needing traceable certification
On-Site Calibration
- Performed directly in your cleanroom or production area
- Minimizes downtime and ensures continuous process flow
- Available for emergency or scheduled maintenance
Comprehensive Instrument Calibration
We support a broad spectrum of pharmaceutical equipment and instruments, including but not limited to:
- Temperature and humidity sensors
- Pressure gauges and transmitters
- Mass balances and scales
- pH meters
- Spectrophotometers
- Autoclaves
- Refrigerators, freezers, and stability chambers
- Analytical testing equipment
Every calibration service includes detailed as-found/as-left data, traceable certificates, and corrective action documentation where required.
ISO 17025-Accredited Calibration
Our laboratory is ISO/IEC 17025 accredited, guaranteeing that all calibrations are performed using validated methods, traceable standards, and highly trained technicians. This level of accreditation is critical for pharmaceutical companies operating under Good Manufacturing Practices (GMP) and FDA oversight.
Customized Calibration Schedules and Programs
We understand that no two pharmaceutical environments are the same. That’s why we offer tailored calibration programs based on:
- Usage frequency
- Manufacturer specifications
- Process criticality
- Audit history and quality risk
Our team works closely with your quality assurance and production personnel to develop a calibration matrix that ensures full equipment coverage and regulatory alignment.
Digital Calibration Certificates and Audit-Ready Records
All our calibration activities are digitally documented, enabling instant access to:
- Calibration certificates
- Deviation reports
- Corrective actions
- Maintenance history
Our 21 CFR Part 11-compliant systems ensure that data is tamper-proof, version-controlled, and always ready for regulatory inspection.
Pharmaceutical Environmental Monitoring Calibration
Environmental conditions in pharmaceutical manufacturing must remain within strict specifications. We specialize in the calibration of:
- Cleanroom particle counters
- Differential pressure sensors
- Temperature and humidity monitoring systems
- HEPA filter test equipment
Routine calibration of these instruments ensures ongoing control of contamination, a cornerstone of sterile manufacturing environments.
Calibration for Validated Systems and Equipment
All pharmaceutical calibration activities must be compatible with your validated processes. Our protocols are designed to integrate seamlessly with your:
- Process validation requirements
- Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Change control and deviation handling procedures
We ensure our calibration practices do not invalidate any part of your validated state while still delivering accurate, compliant outcomes.
Emergency Calibration and Service Support
Unexpected equipment drift or failure can compromise an entire production batch. Our emergency response team is ready to provide:
- Rapid on-site diagnostics
- Expedited calibration services
- Temporary instrumentation
- Root cause analysis
This 24/7 support ensures that critical equipment is restored to compliance with minimal disruption to your operations.
Traceability to National and International Standards
Every calibration we perform is fully traceable to NIST (National Institute of Standards and Technology) or equivalent international standards. Our reference equipment is routinely verified, and our technicians undergo continuous training and proficiency assessments.
Data Integrity and Regulatory Readiness
Data integrity is a cornerstone of pharmaceutical quality systems. Our services help maintain compliance with:
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- ICH Q9 (Quality Risk Management)
We provide audit support, CAPA documentation, and ensure that all calibration records align with your Quality Management System (QMS).
GxP-Compliant Calibration Reports
Our calibration documentation is designed with GxP compliance in mind. Each report includes:
- Instrument details and unique ID
- Location and responsible department
- Tolerance specifications and reference standards
- Pre- and post-calibration values
- Technician ID and approval sign-off
- Recommendations and observations
This standardized approach simplifies regulatory audits and provides complete traceability.
Integrated Asset Management and Scheduling
Managing calibration schedules can be overwhelming. We provide full asset management support, including:
- Automated reminders for upcoming calibration
- Centralized equipment database
- Maintenance and calibration syncing
- Decommissioning support for outdated instruments
Our cloud-based portals give your team real-time visibility into the status of every instrument, allowing you to maintain an audit-ready state year-round.
Training and Consultation
In addition to hands-on calibration services, we offer onsite and virtual training on:
- Calibration best practices
- Regulatory trends
- Deviation prevention strategies
- SOP development and documentation control
Our consultants provide gap assessments and compliance audits to help you identify risks before regulatory bodies do.
Industries We Serve
Our calibration services are trusted by pharmaceutical manufacturers, compounding pharmacies, biotech companies, and contract research organizations (CROs) across the United States. We support operations from early-phase R&D through commercial manufacturing.
Partner With a Leader in Pharmaceutical Calibration
When your operations demand flawless accuracy, regulatory confidence, and dedicated service, we deliver. With decades of industry experience, our team is prepared to be your long-term calibration partner, providing services that exceed compliance and elevate performance.
Contact us today to schedule a calibration consultation or to learn more about how our tailored programs can strengthen your quality control systems.
