ISO/IEC 17025:2017 calibration + biological testing · Valid through 2027
What FDA cGMP requires from your equipment qualification program
21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals — applies to every facility manufacturing FDA-regulated drug products. Subpart D, Section 211.68, addresses automatic, mechanical, and electronic equipment used in manufacturing — and is the regulatory hinge that any FDA inspector will examine when reviewing your equipment qualification program.
The regulation is short. The audit consequence of getting it wrong is not.
"Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance."
— FDA 21 CFR 211.68(a)
The cleanest path to compliance is calibration performed by an ISO/IEC 17025 accredited laboratory under documented scope. That's what A2LA Cert 2039.01 — Allometrics' ISO/IEC 17025:2017 calibration accreditation — delivers. Every certificate of calibration carries the cert number, the NIST-traceable measurement chain, the measurement uncertainty (which 21 CFR 211 expects), and the third-party-verified competency that an FDA inspector recognizes immediately.
The cGMP services map
Every service Allometrics and the Allometrics Group deliver under FDA cGMP / 21 CFR 211:
| Service | What it covers | Spoke page |
|---|---|---|
| Calibration (cGMP / pharma) | A2LA Cert 2039.01 ISO/IEC 17025 calibration directly satisfying 21 CFR 211.68. Onsite, pickup-and-drop-off, and lab-based modes. | Calibration (cGMP / pharma) → |
| Cleanroom certification | Annual and semi-annual recertification of ISO Class 5/6/7/8 cleanrooms supporting cGMP manufacturing. CETA RCCP and NSF Accredited Technicians. | Cleanroom certification → |
| Cleanroom commissioning | IQ/OQ/PQ commissioning of new and renovated cGMP cleanroom space. Delivered by Precision Biotech Solutions. | Cleanroom commissioning → |
| Biosafety cabinet certification | NSF/ANSI 49 certification of BSCs, LAFWs, CAIs, CACIs supporting cGMP and BSL-2/3 research operations. | BSC certification → |
| Environmental monitoring | Viable air, surface, and gloved fingertip sampling under A2LA Cert 7533.01 by Taylor Lake Laboratories. | Microbial testing → |
| Air balancing (TAB) | NEBB-credentialed TAB by Precision Biotech Solutions. Cleanroom HVAC balance, pressure cascades. | Air balancing / TAB → |
| Fume hood certification | ANSI/ASSP Z9.5 fume hood certification for cGMP labs and manufacturing facilities with chemical handling. | Fume hood certification → |
| Temperature & humidity mapping | cGMP warehouse, ULT freezer, stability chamber, and biorepository mapping. IQ/OQ/PQ qualification reports. | Mapping → |
What an FDA cGMP equipment qualification program needs to demonstrate
Documented method validation. Every calibration procedure validated against the relevant standard, with validation records on file. ISO/IEC 17025 Clause 7.2 makes this answerable.
Personnel competency. Each calibration technician with documented training and demonstrated competency. ISO/IEC 17025 Clause 6.2 covers this.
NIST traceability. Every reference standard calibrated by another A2LA-accredited lab, with the unbroken traceability chain documented back to NIST. ISO/IEC 17025 requires this.
Measurement uncertainty. Every calibration result reports uncertainty per ISO/IEC 17025 Clause 7.6. Unaccredited certificates often omit this. FDA inspectors expect to see it.
Quality management system. A facility QMS that catches calibration errors and corrects them. ISO/IEC 17025 Clause 8 makes this answerable in writing.
A written calibration program. 21 CFR 211.68(a) explicitly requires "a written program designed to assure proper performance." Allometrics provides scheduled service contracts that constitute that written program plus the supporting calibration certificates.
21 CFR Part 11–compliant electronic records. Calibration data managed in IndySoft — validated audit trails, controlled access, electronic signatures.
Inspector questions an FDA investigator asks
- "Show me your written calibration program for this equipment."
- "What is the calibration interval, and what's the basis for that interval?"
- "Show me the calibration certificate for this instrument. Is the laboratory that performed it accredited? Under what scope?"
- "What's the measurement uncertainty? Is it within the specification for this process?"
- "What was the as-found condition of this instrument at last calibration? What was the as-left condition? Was an investigation performed if it was out of tolerance?"
A facility using A2LA-accredited calibration answers all of these in writing in minutes. A facility using unaccredited calibration cannot — not because the calibration is wrong, but because the structural framework that produces the documentation is absent.
The Allometrics Group integrated stack — for cGMP buyers specifically
When new cGMP space is built, Precision Biotech Solutions commissions it. When equipment in that space needs calibration, Allometrics performs that work under A2LA Cert 2039.01 — the certificate that directly satisfies 21 CFR 211.68. When the cleanroom enters service, Allometrics certifies it on the recurring schedule cGMP requires. When environmental monitoring is needed, Taylor Lake Laboratories handles the incubation and microbial identification under A2LA Cert 7533.01.
One Group, three accreditation chains, end-to-end coverage of the cGMP equipment and environmental qualification program.
Audit-time guarantee. If a calibration, certification, or qualification report we delivered is challenged in an FDA, USP, or sponsor audit, we will address it.