Quick Answer
Prism Calibration Centre (NABL CC-2480) provides complete pharmaceutical instrument calibration in Gujarat: analytical balances, autoclaves, stability chambers, HPLC, dissolution apparatus, pH meters, temperature data loggers, and cleanroom instruments — with FDA 21 CFR Part 11-compliant documentation packages.
Key Takeaways
- FDA 21 CFR Part 211.68 requires calibration of all equipment used in pharmaceutical manufacturing.
- Schedule M (India GMP) mandates calibration of weighing, temperature, and pressure instruments.
- ICH Q1A stability testing requires NABL-calibrated stability chamber instruments.
- WHO prequalification requires ILAC MRA-recognised calibration (Prism's NABL CC-2480 qualifies).
- Prism manages AMC for 200+ pharma companies in Gujarat with dedicated pharma calibration engineers.
Regulatory Requirements for Pharma Calibration in Gujarat
| Regulation | Calibration Requirement |
|---|---|
| FDA 21 CFR Part 211.68 | Calibration of all equipment used in pharma manufacturing |
| Schedule M (India GMP) | Calibration of measuring and testing instruments |
| WHO GMP (TRS 986) | Annual calibration with NABL-traceable certificates |
| ICH Q1A (R2) | Stability chambers: calibrated temperature and humidity sensors |
| ISO 17034 (RM) | Reference material labs: NABL calibration mandatory |
| EU GMP Annex 15 | Qualification of calibration instruments for equipment qualification |
| WHO PQ (prequalification) | ILAC MRA-recognised NABL calibration required |
Complete Pharma Calibration Instrument List
- Analytical balances (micro, semi-micro, analytical) — dispensing, QC, R&D
- Autoclaves — temperature mapping, sensor calibration, Fo calculation
- Stability chambers (ICH zones) — temperature, humidity mapping
- HPLC (column oven, UV detector, pump flow rate, pressure)
- Dissolution apparatus (speed, temperature — USP <711>)
- pH meters and electrodes (reaction pH, WFI/PW pH)
- Conductivity meters (WFI < 1.3 µS/cm, PW < 2.1 µS/cm)
- Temperature data loggers (cold rooms, freezers, stability chambers)
- Differential pressure gauges (cleanroom monitoring)
- Particle counters (cleanroom classification)
- Sterility testing equipment
- Karl Fischer titrators (moisture determination)
FDA-Ready Calibration Documentation
Prism provides complete FDA-audit-ready calibration documentation packages: NABL calibration certificates for all instruments, calibration register with instrument list and due dates, calibration procedures (SOPs), reference standard certificates with traceability chain, out-of-calibration investigation reports, and change control documentation for instrument repairs. Our pharma clients have successfully passed 50+ FDA and EU GMP inspections with Prism's calibration documentation.
Frequently Asked Questions
How does Prism support pharma companies during FDA inspections?
Prism provides: complete calibration certificate packages for all instruments, traceability statements, reference standard certificates, calibration procedure documents, and historical calibration records. Our dedicated pharma team is available 24/7 during FDA inspection periods to provide additional documentation.
Is Prism's NABL calibration accepted by WHO for prequalification?
Yes. Prism's NABL CC-2480 carries ILAC MRA recognition. WHO requires calibration traceability through an ILAC MRA-signatory NMI — our certificates meet this requirement.
Can Prism calibrate all instruments in a pharmaceutical QC laboratory?
Yes. Prism calibrates all pharma QC lab instruments: analytical balances, pH meters, conductivity meters, dissolution apparatus, HPLC accessories, Karl Fischer titrators, and all temperature/pressure instruments.
How long does it take for Prism to complete pharma plant calibration?
A typical pharma manufacturing unit with 100–300 instruments can be fully calibrated within 2–5 days. For larger plants with 500+ instruments, Prism schedules phased calibration visits over 1–2 weeks.
Does Prism maintain calibration history records for pharma clients?
Yes. Prism maintains digital calibration records for all pharma clients, accessible on request. Records are retained for 10 years per Schedule M requirements.
Written by
Er. Parthiv Kinariwala
Managing Director · Prism Calibration Centre · NABL CC-2480 · Ahmedabad
Er. Parthiv Kinariwala founded Prism Calibration Centre in 2004 and has over 20 years of hands-on experience in calibration engineering, NABL accreditation, and industrial compliance. His team performs 10,000+ calibrations annually from the Vatva GIDC laboratory, serving 5000+ industries across Gujarat.
Prism Calibration Centre — Vatva GIDC, Ahmedabad
Prism Calibration Centre
F-101, Rudraksh Complex 2, Phase 3, GIDC Vatva, Near Jasoda Nagar Cross Road, Ahmedabad — 382445, Gujarat, India
Phone: +91 98245 26444
Email: info@prismcalibration.com
NABL: CC-2480 · ISO/IEC 17025:2017
Hours: Mon–Sat, 9:00 AM – 7:00 PM