EU GMP Annex 15 · ISPE · FDA · NABL CC-2480 · Est. 2004
DQ / IQ / OQ / PQ
Qualification Services
Gujarat's trusted DQ/IQ/OQ/PQ qualification partner — EU GMP Annex 15, ISPE Baseline Guides, FDA Process Validation 2011, ICH Q8/Q9/Q10, Schedule M compliant. Full qualification lifecycle from VMP writing to periodic review. Onsite across Gujarat.
GMP Validated
WHO · EU · FDA
Annex 15
EU GMP Standard
— WHAT IS DQ / IQ / OQ / PQ —
Equipment Qualification —
The Foundation of GMP Compliance
DQ/IQ/OQ/PQ is the four-phase qualification lifecycle that provides documentary evidence that equipment and systems are designed, installed, operate, and perform consistently within defined parameters — the regulatory foundation for all pharmaceutical, biotech, and medical device manufacturing.
DQ — Design Qualification
Documented verification that the proposed design of the facilities, systems, and equipment is suitable for the intended purpose and meets user requirements before procurement.
IQ — Installation Qualification
Documented verification that the equipment is delivered and installed correctly — all utilities, instruments, materials, safety devices, and software documented as per approved specifications.
OQ — Operational Qualification
Documented verification that the equipment operates correctly at all process parameter settings, including worst-case conditions, before product is placed in the equipment.
PQ — Performance Qualification
Documented verification that the equipment consistently produces output meeting specifications under actual or simulated production conditions — the final sign-off before routine use.
Qualification Scope — What Prism Covers
EU GMP Annex 15 / ISPE Risk-Based Approach
Qualification Documentation Checklist
Validation Master Plan (VMP)
Facility-level qualification strategy
User Requirement Specification (URS)
Functional & performance requirements
Risk Assessment
ICH Q9 / FMEA impact assessment
DQ Protocol & Report
Design review vs URS / regulatory
IQ Protocol & Report
Installation verification checklist
OQ Protocol & Report
Operational parameter testing
PQ Protocol & Report
Production-condition performance
— WHAT YOU GET —
Every DQ/IQ/OQ/PQ Package Includes
Complete qualification lifecycle — from VMP and protocol writing to onsite execution and GMP report delivery.
VMP & Protocol Writing
Validation Master Plan, URS, Risk Assessment, and DQ/IQ/OQ/PQ protocols written per EU GMP Annex 15 and ISPE standards before execution starts.
Onsite Protocol Execution
Qualified engineers execute all IQ/OQ/PQ protocols at your facility with NABL-calibrated instruments. No equipment needs to be removed.
Risk-Based Qualification Scope
ICH Q9-based impact assessment determines depth of qualification for each system — direct impact vs indirect impact vs no impact classification.
GMP Qualification Reports
DQ/IQ/OQ/PQ protocols and reports, deviation log, CAPA register, and Final Validation Summary Report — all in EU GMP Annex 15 format.
Fast Report Turnaround
Individual qualification reports delivered within 5–7 working days. Full facility packages delivered per agreed project milestones.
NABL-Calibrated Test Instruments
All test instruments (temperature, pressure, flow, electrical) used during IQ/OQ/PQ are NABL CC-2480 calibrated — full traceability in all reports.
Change Control & Requalification
Prism provides change control procedures and requalification protocols — lifecycle qualification management to keep your facility perpetually GMP-compliant.
Retrospective Qualification
Legacy equipment without original qualification records can be retrospectively qualified using equipment history, maintenance records, and gap studies.
Onsite Across Gujarat · EU GMP Annex 15 · ISPE
Need DQ / IQ / OQ / PQ for Your Equipment?
Full qualification lifecycle · VMP writing · 7-day report delivery
— OUR PROCESS —
DQ / IQ / OQ / PQ — The Qualification Lifecycle
Every qualification follows the GMP lifecycle approach per EU GMP Annex 15 (2015) and ISPE Risk-Based Approach to Commissioning and Qualification.
Design Qualification (DQ)
Review and verify that the equipment/system design meets the defined user requirements specification (URS) and applicable regulatory standards. DQ report documents compliance of design drawings, material of construction, vendor qualification, and calibration requirements.
Installation Qualification (IQ)
Verification that the equipment/system is installed correctly per approved drawings, manufacturer recommendations, and regulatory requirements. IQ covers utilities, instruments, materials, spare parts, safety features, and software version documentation.
Operational Qualification (OQ)
Verification that the equipment/system operates consistently within defined operating parameters across the full operating range — including worst-case conditions. OQ challenges all critical process parameters (CPPs) against pre-defined acceptance criteria.
Performance Qualification (PQ)
Verification that the equipment/system performs consistently and reproducibly to produce output meeting specification under actual manufacturing conditions. PQ uses product or product simulant at worst-case conditions with full statistical evaluation.
Deviation & CAPA Management
Any test failures, OOS results, or deviations from acceptance criteria during DQ/IQ/OQ/PQ are documented with root cause analysis and CAPA. Qualification is not signed off until all deviations are resolved and CAPA effectiveness confirmed.
Validation Report & Lifecycle
Complete validation package issued: VMP, DQ/IQ/OQ/PQ protocols and reports, deviation log, CAPA register, and Periodic Review schedule — all per EU GMP Annex 15 and ISPE Risk-Based approach. GMP lifecycle maintained with change control.
Industry Applications
Industries That Require DQ / IQ / OQ / PQ
Pharmaceutical Manufacturing
Full DQ/IQ/OQ/PQ for all pharmaceutical manufacturing equipment and utilities per EU GMP Annex 15 (2015), Schedule M (2023), and ISPE Baseline Guides.
Know MoreAPI / Bulk Drug Synthesis
Qualification of API synthesis reactors, crystallizers, dryers, and associated utilities per FDA 21 CFR Part 211 and ICH Q11.
Know MoreMedical Device Manufacturing
Equipment and process validation per ISO 13485, IQ/OQ/PQ per GHTF SG3 N99-10:2004, and EU MDR 2017/745 Annex IX/XI.
Know MoreBiotechnology & Biologics
Bioreactor, centrifuge, and downstream processing equipment DQ/IQ/OQ/PQ per ICH Q5A/Q6B and FDA 21 CFR Part 600.
Know MoreHospital & Healthcare
Medical equipment qualification for hospital pharmacies, blood banks, CSSD, and surgical suites per NABH and MoHFW guidelines.
Know MoreFood & Beverage Processing
Processing equipment validation for food manufacturers per FSSAI, FSSC 22000, and Codex Alimentarius HACCP requirements.
Know MoreNutraceuticals & Cosmetics
Equipment qualification for nutraceutical, dietary supplement, and cosmetics manufacturers per GMP and ASEAN Cosmetic GMP guidelines.
Know MoreChemical & Specialty Materials
Process equipment DQ/IQ/OQ/PQ for specialty chemical manufacturers requiring ISO 9001 or GMP-level process validation documentation.
Know MoreWhy Choose Prism
Two Decades of GMP Qualification.
Zero Audit Observations.
Since 2004, every DQ/IQ/OQ/PQ qualification report issued by Prism has been accepted by USFDA, WHO GMP, EU GMP, GPCB, and NABH auditors — no observations, no rework.
— STANDARDS & COMPLIANCE —
Standards We Follow for DQ / IQ / OQ / PQ
EU GMP Annex 15 (2015)
Qualification and validation
ISPE Risk-Based C&Q
ISPE Baseline Guide: Commissioning
FDA Process Validation 2011
FDA guidance process validation
ICH Q8(R2) / Q9 / Q10
Pharmaceutical development, risk
FDA 21 CFR Part 211
Current GMP for finished pharma
WHO TRS 961 / TRS 970
WHO GMP supplementary guidelines
GHTF SG3 N99-10:2004
Process validation — medical devices
ISO/IEC 17025:2017
NABL accreditation CC-2480
NABL CC-2480 + 20 Years GMP Qualification
All test instruments are NABL calibrated under CC-2480. Every DQ/IQ/OQ/PQ package is accepted by USFDA, WHO, EU GMP, GPCB, and NABH — zero observations since 2004.
3500+
Qualification Packages
0
Audit Observations
— NON-GMP QUALIFICATION —
Equipment Qualification for Non-GMP Facilities
Non-pharmaceutical manufacturers also need documented equipment qualification — for ISO 9001 audits, customer requirements, or internal quality systems. Prism offers flexible IQ/OQ/PQ for non-GMP industries at cost-effective pricing.
NABL-Traceable Instruments
All test instruments NABL CC-2480 calibrated regardless of GMP or non-GMP scope.
Faster Scope
Non-GMP IQ/OQ completed in 3–5 days; full DQ/IQ/OQ/PQ in 7–10 days.
Flexible Documentation
ISO 9001-ready or GMP-ready report format — your choice.
Onsite — No Shutdown
All qualification done at your facility around your production schedule.
Onsite Coverage
Serving All
of Gujarat
Qualification engineers based in Ahmedabad cover the full Gujarat pharma corridor onsite.
— VALIDATION SERVICES —
Validation Services We Offer
8 GMP validation services — all under one NABL-accredited roof. View all services →
Clean Room Validation
4 test parameters
- ISO 14644-1 Particle Count
- HEPA Filter PAO/DOP Test
- ACH & Airflow Velocity
- Differential Pressure Cascade
Autoclave / Sterilizer
4 test parameters
- Temperature Distribution Study
- Heat Penetration Study
- IQ / OQ / PQ Documentation
- Bowie-Dick & Leak Test
Stability Chamber
4 test parameters
- T&H Mapping (ICH Q1A)
- Uniformity Verification
- IQ / OQ / PQ Protocols
- Data Logger Calibration
DQ / IQ / OQ / PQ
4 test parameters
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
AHU Validation
4 test parameters
- Airflow & Velocity Balancing
- HEPA Integrity Testing
- Pressure & ACH Verification
- Filter Efficiency Testing
PLC / Software Validation
4 test parameters
- 21 CFR Part 11 Compliance
- GAMP 5 Validation
- IQ / OQ / PQ for Software
- Audit Trail Verification
Thermography / Oven
4 test parameters
- Hot Air Oven Temperature Mapping
- Thermal Distribution Study
- Infrared Thermography
- IQ / OQ / PQ Documentation
Performance Qualification
4 test parameters
- Worst-Case PQ Testing
- Process Performance Study
- Statistical Acceptance Criteria
- GMP-Ready PQ Report
— Our Clients —
Trusted By Gujarat's Leading Pharma Companies
— CLIENT VOICES —
What Our DQ/IQ/OQ/PQ Clients Say
Prism completed DQ/IQ/OQ/PQ for 12 new manufacturing systems in our greenfield facility — autoclaves, stability chambers, AHU, clean rooms, and process equipment. Full validation packages delivered in 3 weeks, accepted in WHO GMP pre-approval inspection without a single observation.
We engaged Prism for DQ/IQ/OQ/PQ of our new injectables manufacturing line. Their validation protocols were written to ISPE Baseline Guide standards and accepted by USFDA during their PAI audit. Excellent GMP documentation quality.
Prism's DQ/IQ/OQ/PQ service for our new API facility — all equipment and utilities qualified per EU GMP Annex 15 and ISPE Risk-Based approach. Validation Master Plan, individual equipment VPs, and final validation reports all delivered on schedule.
Prism completed DQ/IQ/OQ/PQ for 12 new manufacturing systems in our greenfield facility — autoclaves, stability chambers, AHU, clean rooms, and process equipment. Full validation packages delivered in 3 weeks, accepted in WHO GMP pre-approval inspection without a single observation.
We engaged Prism for DQ/IQ/OQ/PQ of our new injectables manufacturing line. Their validation protocols were written to ISPE Baseline Guide standards and accepted by USFDA during their PAI audit. Excellent GMP documentation quality.
Prism's DQ/IQ/OQ/PQ service for our new API facility — all equipment and utilities qualified per EU GMP Annex 15 and ISPE Risk-Based approach. Validation Master Plan, individual equipment VPs, and final validation reports all delivered on schedule.
Prism completed DQ/IQ/OQ/PQ for 12 new manufacturing systems in our greenfield facility — autoclaves, stability chambers, AHU, clean rooms, and process equipment. Full validation packages delivered in 3 weeks, accepted in WHO GMP pre-approval inspection without a single observation.
We engaged Prism for DQ/IQ/OQ/PQ of our new injectables manufacturing line. Their validation protocols were written to ISPE Baseline Guide standards and accepted by USFDA during their PAI audit. Excellent GMP documentation quality.
Prism's DQ/IQ/OQ/PQ service for our new API facility — all equipment and utilities qualified per EU GMP Annex 15 and ISPE Risk-Based approach. Validation Master Plan, individual equipment VPs, and final validation reports all delivered on schedule.
Get In Touch
Request a Free Quote
Tell us the equipment or system to qualify, the regulatory requirement, and your timeline. Our team responds within 2 business hours.
— FAQ —
DQ / IQ / OQ / PQ — Frequently Asked Questions
Need DQ / IQ / OQ / PQ in Gujarat?
Call or WhatsApp — we reply within the hour. Full qualification lifecycle, GMP report guaranteed.
Prism Calibration Centre · F 101, Rudraksh Complex 2, Phase 3, GIDC Vatva, Ahmedabad, Gujarat 382445
— FROM OUR BLOG —
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Read MoreValidation Services Disclaimer
DQ/IQ/OQ/PQ qualification services are performed per EU GMP Annex 15 (2015), ISPE Risk-Based Approach, FDA Process Validation guidance (2011), and applicable regulatory guidelines. All test instruments are NABL calibrated under Certificate CC-2480 (ISO/IEC 17025:2017).