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.
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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