Equipment
Validation Services
IQ/OQ/PQ · WHO GMP · ISO 14644
Complete DQ/IQ/OQ/PQ qualification and validation services for pharma, food, chemical, healthcare, and manufacturing industries in Gujarat. Clean room, autoclave, stability chamber, AHU, PLC/SCADA — protocol to final report.
WHO GMP · Schedule M
NABL CC-2480 Data
— OUR VALIDATION SERVICES —
Complete Pharmaceutical Validation Scope
From clean room qualification to PLC validation — full WHO GMP and Schedule M compliant validation with NABL-traceable instrumentation data.
Clean Room Validation
ISO 14644-1 clean room qualification and performance testing. Particle count, air change rate, temperature & humidity mapping, HEPA filter integrity (DOP/PAO test), pressure differential, and microbial monitoring.
Autoclave / Sterilizer Validation
Steam sterilizer validation for pharmaceutical and healthcare. IQ / OQ / PQ qualification, temperature distribution study (TDS), heat penetration study, Bowie-Dick test, and biological indicator (BI) validation.
Stability Chamber Validation
ICH Q1A stability chamber qualification — temperature and humidity mapping (IQ/OQ/PQ), temperature uniformity study, alarm verification, and recovery time study. For pharma, API, and drug product stability storage.
DQ / IQ / OQ / PQ
Full design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for all pharmaceutical manufacturing and quality control equipment.
AHU Validation
Air Handling Unit (AHU) qualification — airflow velocity, air change rate, HEPA filter integrity (DOP test), room pressure cascade, temperature/humidity uniformity, and smoke study for clean room areas.
PLC / Software Validation
21 CFR Part 11 and GAMP 5 compliant computer system validation (CSV) for PLC, SCADA, DCS, and pharmaceutical manufacturing software. IQ/OQ/PQ for automated systems.
Thermography / Oven Validation
Hot air oven, tunnel oven, and depyrogenation tunnel validation. Temperature distribution study (TDS), uniformity study, load pattern study, and F₀ / F(h) calculation for heat sterilization processes.
Performance Qualification
Process performance qualification (PPQ) for all pharmaceutical manufacturing processes — blending, granulation, compression, coating, and filling. Documented protocols and reports per current GMP guidelines.
— WHY CHOOSE PRISM —
Gujarat's Most Trusted Pharma Validation Partner
500+ validation projects completed across Gujarat pharma clusters with zero FDA 483 observations — since 2004.
WHO GMP & Schedule M Expertise
Deep expertise in WHO Technical Report Series and India's Schedule M cGMP — ensuring all validation protocols, execution, and reports meet current regulatory expectations.
USFDA / EU GMP Ready Documentation
Validation documentation prepared to USFDA 21 CFR Part 211 and EU GMP Annex 1, 11 standards — ready for drug master file (DMF) submission and regulatory inspections.
Onsite at Your Pharmaceutical Facility
Qualified validation engineers with specialized equipment travel to your pharma plant across Gujarat — Ahmedabad, Vadodara, Ankleshwar, Bharuch, Surat, and Rajkot.
Protocol, Execution & Report — Complete
Prism provides end-to-end service: validation protocol (VP) preparation, on-floor execution, deviation management, and final validation report (VR) in GMP-compliant format.
NABL CC-2480 Traceable Data
All validation data uses NABL CC-2480 calibrated instruments — providing traceable, defensible measurements in FDA inspections and audit data integrity reviews.
20+ Years Pharma Validation
Since 2004, Prism has completed 500+ validation projects for pharma companies across Gujarat — zero FDA 483 observations related to our validation work.
— HOW IT WORKS —
Our Validation Process
Requirement & Protocol
Gap assessment, User Requirement Specification (URS), and Validation Protocol (VP) preparation — reviewed and approved per your site SOP before execution begins.
Instrument Qualification
All instruments used in validation are NABL CC-2480 calibrated — providing traceable, audit-ready calibration data as part of the validation package.
Onsite Execution
Qualified validation engineers execute the approved protocol at your facility — recording all data, managing deviations, and maintaining GMP-compliant documentation.
Report & Certification
Final Validation Report (VR) with all raw data, deviation assessment, and qualified/not-qualified conclusion — ready for regulatory submission and internal GMP records.
— STANDARDS & COMPLIANCE —
Validation Documentation Accepted by Global Regulators
All Prism validation protocols and reports are prepared to meet global regulatory requirements — accepted in USFDA, EU GMP, WHO, and Schedule M inspections.
Two protocols account for most of the work we are asked for: our autoclave calibration and validation guide covers temperature mapping and Fo value under ISO 17665, and cleanroom qualification in Ahmedabad explains the ISO 14644 tests and the instruments each one needs. If the terms themselves are the confusion, calibration vs verification vs validation settles what each one means under ISO 9001.
WHO GMP TRS
World Health Organization GMP Guidelines
Schedule M India
Indian Pharmaceutical GMP (Revised 2023)
21 CFR Part 211
US FDA Drug GMP Regulations
EU GMP Annex 1/11
European Union GMP for Sterile Products
ISO 14644-1
Clean Room Classification Standard
ICH Q7 / Q10
International Pharma Harmonisation
GAMP 5
Good Automated Manufacturing Practice
NABL CC-2480
Traceable Calibration Data for Validation
Complete Validation Package
Prism delivers end-to-end validation — URS, DQ, IQ, OQ, PQ protocol preparation, execution, deviation management, and final report — with NABL-calibrated instrument data in a single, audit-ready package.
- URS & DQ document preparation
- Protocol & SOP preparation
- Onsite execution with NABL instruments
- Deviation management & CAPA
- Final report with conclusion
- Ready for regulatory inspection
500+
Projects Done
0
FDA 483s
20+
Years
— WHY CHOOSE PRISM —
NABL CC-2480 · 20+ Years ·
5000+ Clients Served
Since 2004, Prism Calibration Centre has been Gujarat's most trusted NABL-accredited calibration and compliance partner — with zero audit failures across 20+ years.
— INDUSTRIES WE SERVE —
Validation Services for Every Gujarat Industry
Pharma · Chemical · Biomedical · Food · Manufacturing · Power — Prism validates for every regulated industry requiring qualification documentation.
Pharmaceuticals & Biotech
DQ/IQ/OQ/PQ validation for pharma manufacturing equipment. WHO GMP, Schedule M, and 21 CFR Part 11 compliant.
Know MoreHealthcare & Hospitals
Biomedical instrument validation and clean room certification for hospitals, diagnostic labs, and OT environments.
Know MoreChemical & Process Industry
Process equipment validation and PLC/SCADA software validation for chemical reactors and process control systems.
Know MoreFood & Beverage
Equipment validation and HACCP-compliant qualification for food processing, packaging, and sterilization systems.
Know MoreOil & Gas
Validation for process instruments, control panels, and safety systems in oil, gas, and petrochemical facilities.
Know MoreAerospace & Defense
Validation of measurement systems and test equipment to aerospace quality and traceability standards.
Know MoreMedical Device Manufacturing
IQ/OQ/PQ qualification for medical device production equipment. ISO 13485 and CE mark compliance support.
Know MoreGovernment & Research Labs
Validation services for government testing laboratories, NABL-accredited labs, and national metrology bodies.
Know More— WHERE WE SERVE —
Onsite Service
Across Gujarat
Engineers travel to your facility with portable reference standards. No instrument removal, zero production downtime. All GIDC zones and industrial areas covered.
WHO GMP · Schedule M · 21 CFR Part 211 · EU GMP
Need Validation for Your Pharma Facility?
Protocol to report · NABL-calibrated data · Audit-ready documentation
— FAQs —
Pharmaceutical Validation — FAQs
— GET IN TOUCH —
Talk to Our Validation
Experts
New facility qualification, revalidation, FDA inspection preparation, or Schedule M compliance — describe your requirement and we 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
Request a Free Quote
— FROM OUR BLOG —
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