Pharmaceutical
Accredited calibration and NIST-traceable measurement documentation — supporting our customers' GMP validation and 21 CFR Part 211 programs.
Calibration for pharmaceutical
Pharmaceutical and biotech operations require validated, traceable measurement across thermal, chemical, and process domains. FCI supports cGMP environments (21 CFR 210/211) and ICH expectations with calibration documentation suited to validation and audit, including chamber and process-temperature mapping studies that document spatial uniformity and stability.
Data integrity matters in regulated manufacturing. FCI's certificates capture as-found and as-left readings with full NIST traceability and expanded uncertainty at a 95% confidence level — the defensible record that validation protocols and FDA inspections demand.
Why FCI for this sector
- cGMP (21 CFR 210/211) & ICH alignment
- Chamber & process temperature mapping
- Validation-traceability records
- Chemical & pH instrument support
Pharmaceutical calibration questions
Do you support GMP and 21 CFR Part 211 programs?
Yes. cGMP and ICH guidance require calibrated, traceable equipment. Our accredited calibration records and validation traceability support those programs.
What do you calibrate for pharmaceutical manufacturers?
Chamber and process-temperature mapping, pH and chemical instruments, and the thermal, electrical, mechanical and pressure equipment used in production and QC.
What is on every certificate?
Every certificate is issued under our ISO/IEC 17025:2017 accreditation (IAS CL-112) and records as-found and as-left readings at each test point, with measured values, tolerances and expanded uncertainty at 95% confidence (k=2).
How fast is a quote?
Returning customers get a written quote within one business day. New customers and new equipment go through ISO/IEC 17025 contract review in three to five business days.