Calibration for cGMP and pharma — built to survive FDA inspection

A2LA · Cert 2039.01 · Allometrics, Inc.
ISO/IEC 17025:2017 calibration
Valid through April 30, 2027

If you operate a compounding pharmacy, a 503B outsourcing facility, a pharmaceutical manufacturing plant, or an ATMP / cell & gene therapy site, your calibration program is judged by a single yardstick: will the certificates and documentation survive an FDA inspection on first review? Allometrics' cGMP calibration practice is built around that question.

What's specific about cGMP calibration

FDA 21 CFR 211.68 — the regulation that governs equipment used in pharmaceutical manufacturing. Calibration certificates must demonstrate NIST traceability, measurement uncertainty per ILAC P14 / GUM, and pass/fail determination against pre-defined tolerance limits.

USP <1058> Equipment Qualification — equipment classified into EQL-1 through EQL-3 levels based on impact to product quality. Each level requires different IQ/OQ/PQ rigor. Allometrics writes IQ/OQ/PQ documentation aligned to your equipment's EQL classification.

USP <797>, <800>, <825> — pharmacy compounding standards that explicitly call out balance, scale, and pressure-monitoring calibration requirements. Allometrics' certificates are written to satisfy state board of pharmacy reviews.

Audit-survivable certificate format — every certificate includes the full NIST traceability chain, environmental conditions, as-found and as-left readings, measurement uncertainty, and the A2LA Cert 2039.01 reference. Format proven to survive FDA Form 483 reviews.

21 CFR Part 11 electronic records support — when your calibration data must live in a validated electronic system, we deliver records in formats that satisfy Part 11 audit trail requirements.

The cgmp / pharma calibration services map

This page is the cross-cut overview. Every actual calibration is performed under one of the 15 metrology discipline pages — see your equipment type below:

Why Allometrics for cgmp / pharma calibration

A2LA-accredited under ISO/IEC 17025. Cert 2039.01. Continuous accreditation through every revision.

One team for the entire regulated environment. Calibration, cleanroom certification, biosafety cabinet certification, viables testing, fume hood certification, and HVAC balancing — all under one accreditation chain. Replace 3–5 vendors with one accredited partner.

50 years of regulated-environment experience. Founded 1976. The team has lived every USP revision, every FDA cGMP guidance update, every Joint Commission standards change.