Calibration, Validation
& GMP Compliance
for Pharma Manufacturers
Gujarat's most trusted NABL-accredited partner for pharmaceutical calibration, GMP validation, EHS compliance, and regulatory consulting. Serving 500+ pharma companies since 2004. Accepted by WHO · EU GMP · FDA · CDSCO.
GMP Compliant
WHO · EU · FDA
NABL CC-2480
Since 2004
— WHY IT MATTERS —
Why Pharmaceutical Companies
Need Calibration & Validation
In pharma, every measurement affects a patient. A miscalibrated instrument is not just a compliance gap — it's a safety risk, a regulatory violation, and a financial liability.
Patient Safety — Non-Negotiable
Inaccurate instruments mean wrong doses, contaminated batches, and incorrect potency. A miscalibrated balance by 0.1 g can render an entire batch ineffective or toxic — directly harming patients.
GMP Compliance is Mandatory
Schedule M India (2023), WHO GMP, EU GMP Annex 1, and FDA 21 CFR Part 211.68 mandate that every measuring instrument be calibrated with NABL-traceable certificates. No calibration = GMP violation.
Export Market Access
US FDA, EU EMA, and WHO prequalification require NABL-traceable calibration records during facility inspection. Missing certificates result in import alerts, port rejection, and loss of export access.
Batch Consistency & Quality
Every tablet weight, capsule fill, and API concentration depends on calibrated instruments. Drift in a balance or temperature sensor causes batch-to-batch variation — leading to OOS results.
Audit Readiness — CDSCO, FDA, WHO
During regulatory inspections, auditors specifically ask for NABL-traceable calibration certificates. Missing records = 483 observations, warning letters, or manufacturing licence suspension.
Avoid Recalls & Financial Loss
A batch recall due to instrument error costs ₹10–50 crore. Annual NABL calibration costs a fraction of that — it is the cheapest insurance against regulatory action and product recall.
— SCOPE OF CALIBRATION —
Which Instruments in Your Pharma Plant Need Calibration?
Every measuring instrument that affects product quality or patient safety must be NABL calibrated. Click any instrument to learn more.
Temperature Instruments
Pressure Instruments
Mass & Volume Instruments
— STANDARDS & COMPLIANCE —
Calibration Backed by International
Pharmaceutical Standards
Every calibration and validation at Prism follows a documented, traceable procedure aligned with global pharmaceutical regulatory requirements. Our NABL-accredited certificates satisfy WHO GMP, EU GMP Annex 1, FDA, CDSCO, and Schedule M India audit requirements.
WHO GMP
Good Manufacturing Practice
EU GMP Annex 1 (2022)
Sterile Medicinal Products
FDA 21 CFR Part 211
Finished Pharmaceuticals
Schedule M India (2023)
Indian GMP Standard
ISO/IEC 17025:2017
NABL Accreditation Standard
ICH Q7 / Q10
API & Pharma Quality Systems
NABL CC-2480
Prism Accreditation Number
ISO 9001:2015
Quality Management System
NABL Accreditation — CC-2480
Prism holds NABL accreditation CC-2480 under ISO/IEC 17025:2017, recognized under the ILAC MRA agreement. Our pharma calibration certificates carry the same legal weight as any NABL-accredited lab worldwide — valid for WHO GMP, EU GMP Annex 1, FDA 21 CFR Part 211.68, CDSCO, and Schedule M India (2023) audits.
500+
Pharma Companies Served
200+
Instrument Types Covered
— NON-NABL CALIBRATION —
Non-NABL Pharma Calibration Services by Prism
In addition to our NABL-accredited calibration, Prism also provides non-NABL calibration for pharmaceutical instruments. Non-NABL calibration is ideal when a formal accreditation certificate is not required — offering faster turnaround and cost-effective pricing with the same trained engineers and traceable reference standards.
Traceable Reference Standards
All calibrations use NPL/BIPM-traceable reference standards regardless of whether the certificate is NABL or non-NABL — same accuracy, same engineers.
Faster Turnaround
Non-NABL calibration jobs are typically completed faster — ideal for urgent maintenance, breakdown situations, or bulk batch calibration across your plant.
Cost-Effective Pricing
Non-NABL calibration is priced lower than accredited calibration — the right choice for internal maintenance, R&D labs, or pre-clinical instruments.
Onsite or In-Lab
Available both at our Ahmedabad lab and as onsite service across Gujarat — with or without NABL certification as per your specific requirement.
— OUR SERVICES FOR PHARMA —
Everything a Pharma Plant Needs — Under One Roof
Calibration · Validation · EHS & Audit · Consulting — one NABL-accredited partner.
Calibration
NABL CC-2480 calibration for all pharma instruments — temperature, pressure, mass, electrical — with WHO/FDA/EU GMP accepted certificates.
Validation
Full GMP equipment and facility validation — DQ/IQ/OQ/PQ documentation per EU GMP Annex 1, WHO TRS 970, Schedule M India, and FDA 21 CFR.
EHS & Audit
Environmental, health & safety compliance for pharma plants — GPCB environmental, safety audits, energy audits, HAZOP, and stack emission testing.
Consulting
Regulatory and management consulting — ISO, NABL, HACCP certifications and GMP documentation support with minimal production disruption.
— RISKS OF NON-COMPLIANCE —
What Happens When Pharma Instruments Are Not Calibrated?
The cost of not calibrating is always higher than the cost of calibration.
FDA 483 Observation / Warning Letter
US FDA cites missing or non-traceable calibration as a critical GMP deficiency — resulting in import alerts that can shut down US export business.
WHO Prequalification Rejection
WHO prequalification inspectors require current NABL certificates for all critical instruments. Missing = prequalification revoked.
Batch Rejection at CDSCO Audit
CDSCO drug inspectors check calibration records. Expired or missing certificates can lead to batch condemnation and production stop.
EU Import Ban
EU GMP inspectors verify instrument calibration during facility audit. Non-compliant facilities are placed on the EU non-compliant list.
OOS Investigations & Production Delays
Drifted instruments cause Out-of-Specification results. Every OOS triggers mandatory investigation — costly production halt.
Product Recall & Reputational Damage
A product recall due to instrument-related quality failure costs ₹10–50 crore and permanently damages brand reputation in regulated markets.
Why Choose Prism
Two Decades of GMP Compliance.
Zero Audit Failures.
Since 2004, every NABL calibration certificate and GMP validation report issued by Prism has been accepted by WHO GMP, EU GMP, FDA, and CDSCO auditors — no rejections, no rework, no compliance gaps.
Onsite Coverage
Serving All
of Gujarat
NABL-certified engineers travel to your pharma facility with portable reference standards — no instrument removal, zero production downtime.
NABL CC-2480 · 500+ Pharma Companies · Est. 2004
Need Calibration or Validation for Your Pharma Plant?
Onsite service · Same week appointment · 5–7 day report delivery
— CLIENT TESTIMONIALS —
What Pharma QA Leaders Say About Prism
Prism validated all our clean rooms under EU GMP Annex 1 (2022) and WHO TRS 970. Every report was accepted in our US FDA and WHO GMP audits — zero observations in 5 consecutive inspections.
Dr. Priya Shah
Clean room DQ/IQ/OQ/PQ for our new API block — particle counting, HEPA PAO testing, ACH and T&H mapping done onsite. Report issued in 5 days, accepted directly in EU GMP inspection.
Rajesh Patel
Annual requalification across 12 Grade B/C rooms by Prism. GMP-standard reports with measurement uncertainty. NABL-traceable instruments, professional team, zero rework requests in 6 years.
Kavita Menon
Prism validated all our clean rooms under EU GMP Annex 1 (2022) and WHO TRS 970. Every report was accepted in our US FDA and WHO GMP audits — zero observations in 5 consecutive inspections.
Dr. Priya Shah
Clean room DQ/IQ/OQ/PQ for our new API block — particle counting, HEPA PAO testing, ACH and T&H mapping done onsite. Report issued in 5 days, accepted directly in EU GMP inspection.
Rajesh Patel
Annual requalification across 12 Grade B/C rooms by Prism. GMP-standard reports with measurement uncertainty. NABL-traceable instruments, professional team, zero rework requests in 6 years.
Kavita Menon
Prism validated all our clean rooms under EU GMP Annex 1 (2022) and WHO TRS 970. Every report was accepted in our US FDA and WHO GMP audits — zero observations in 5 consecutive inspections.
Dr. Priya Shah
Clean room DQ/IQ/OQ/PQ for our new API block — particle counting, HEPA PAO testing, ACH and T&H mapping done onsite. Report issued in 5 days, accepted directly in EU GMP inspection.
Rajesh Patel
Annual requalification across 12 Grade B/C rooms by Prism. GMP-standard reports with measurement uncertainty. NABL-traceable instruments, professional team, zero rework requests in 6 years.
Kavita Menon
— FAQs —
Frequently Asked Questions
— GET IN TOUCH —
Talk to Our Pharma
GMP Experts Today
Calibration before a WHO audit, clean room validation, or ISO consulting — tell us what you need and we'll respond within 24 hours.
- +91 98245 26444
- info@prismcalibration.com
- F-101, Rudraksh Complex 2, GIDC Vatva, Ahmedabad – 382445
- Mon – Sat · 9 AM – 7 PM