NABL CC-2480 · EU GMP Annex 15 · FDA Process Validation 2011 · Est. 2004
Performance
Qualification (PQ)
Gujarat's trusted PQ validation partner — worst-case process performance studies, 3-run consecutive PQ, statistical analysis (Cpk), continued process verification (CPV). Full protocols and GMP reports per EU GMP Annex 15, FDA 2011 guidance, ICH Q8/Q9/Q10. Onsite across Gujarat.
GMP Validated
WHO · EU · FDA
EU GMP Annex 15
Process Validation
— WHAT IS PERFORMANCE QUALIFICATION —
PQ Validation —
Process Consistency Proven
Performance Qualification (PQ) provides documented, scientific evidence that your manufacturing process consistently produces product meeting all quality specifications under actual production conditions — at commercial scale, using approved raw materials, personnel, and procedures.
PQ is mandatory — not optional — under EU GMP Annex 15 and FDA guidance
EU GMP Annex 15 (2015) and FDA Process Validation Guidance (2011) mandate formal PQ for all pharmaceutical products. No product may be commercially marketed without documented PQ demonstrating process consistency — this applies to new products, site transfers, batch size changes, and equipment changes.
3 consecutive PQ runs at commercial scale are the regulatory baseline
A minimum of 3 consecutive successful PQ runs, each meeting all pre-defined acceptance criteria, is required by EU GMP Annex 15. Fewer runs require scientific justification. Each run must be at the commercial batch size using actual production conditions — not lab scale.
PQ failure = mandatory batch rejection and regulatory notification
If PQ runs fail to meet acceptance criteria, the process is not validated. Batches produced during a failed PQ run cannot be released unless re-testing is scientifically justified. Repeat PQ failures typically trigger CAPA and regulatory notification in sterile manufacturing.
PQ Acceptance Criteria Framework
EU GMP Annex 15 / FDA 2011 / ICH Q8–Q10
Minimum PQ runs
3 consecutive successful runs
Batch scale
Commercial scale only
Process capability
Cpk ≥ 1.33 for all CQAs
Sampling
Worst-case, bracketed, risk-based
CPV requirement
Stage 3 per FDA 2011 guidance
Report format
EU GMP Annex 15 compliant
— WHAT YOU GET —
Every PQ Engagement Includes
PQ Protocol Development
Comprehensive PQ protocol with test parameters, worst-case sampling plan, acceptance criteria, and statistical evaluation method — approved before execution per EU GMP Annex 15.
Worst-Case PQ Runs
Three consecutive PQ runs at commercial scale — worst-case bracketing at min/max batch size, speed, temperature, and critical process parameters to demonstrate full-range robustness.
Statistical Analysis (Cpk)
Process capability (Cp, Cpk), mean, SD, RSD, and SPC trending for all CQAs — confirming Cpk ≥ 1.33 per FDA 2011 guidance and regulatory expectation.
GMP PQ Report
Full PQ validation report in EU GMP Annex 15 format — run summaries, all analytical data, statistical analysis, deviation log, CAPA records, and conclusion. Accepted by USFDA, WHO, GPCB.
Fast Report Turnaround
Preliminary PQ run findings within 48 hours. Complete GMP PQ validation report with all annexures in 7–10 working days from run completion.
CPV Protocol Setup
Continued Process Verification (CPV) protocol and control chart setup per ICH Q10 and FDA Stage 3 — links PQ outcomes to ongoing APQR and process trending.
Deviation & CAPA Management
All deviations during PQ runs documented, investigated, and CAPAed in real time. No deviations go unaddressed in the final PQ report.
Onsite at Your Facility
Prism validation engineers work at your production facility for the full PQ campaign — no external laboratory, no sample transport risk, no production interruption.
Onsite Across Gujarat · EU GMP Annex 15 · FDA 2011 Guidance
Ready to Qualify Your Process?
Onsite service · 7–10 day report delivery · FDA, WHO, EU GMP accepted
— OUR PROCESS —
Performance Qualification Process
PQ Protocol Development
Prepare a comprehensive PQ protocol defining test parameters, sampling plan, worst-case conditions, acceptance criteria, and statistical evaluation method — aligned with EU GMP Annex 15, FDA Process Validation Guidance (2011), and ICH Q8/Q9/Q10.
Worst-Case Bracketing Study
Execute PQ runs at worst-case process parameters — minimum and maximum batch size, speed, temperature, humidity, and load configuration. Bracketing demonstrates process robustness across the full validated range.
Three Consecutive PQ Runs
Minimum 3 consecutive successful PQ runs at commercial scale, each meeting all pre-defined acceptance criteria — unless a continuous process verification (CPV) approach is used per FDA 2011 guidance.
In-Process & Finished Product Testing
Sampling at defined intervals during each PQ run: blend uniformity, content uniformity, tablet weight variation, dissolution, microbial limits, and all CQA parameters — per the approved PQ sampling plan.
Statistical Analysis & CPV
Process capability analysis (Cp, Cpk), statistical process control (SPC) trending, and continued process verification (CPV) setup per ICH Q10 and FDA Process Validation Guidance (2011) Stage 3 requirements.
GMP PQ Report Issued
Complete PQ validation report including run summaries, all analytical data, statistical analysis, deviation log, CAPA records, conclusion, and approval signatures — in EU GMP Annex 15 format, accepted by FDA, WHO, GPCB auditors.
Industry Applications
Industries That Require Performance Qualification
Solid Dose — Tablet & Capsule
PQ for tablet compression, encapsulation, blending, granulation, and coating processes — content uniformity, blend uniformity, dissolution, and hardness per USP/IP/BP and EU GMP Annex 15.
Know MoreSterile Manufacturing
PQ for sterile filling, lyophilization, sterilization-in-place (SIP), and aseptic processing. Media fill validation as part of aseptic process PQ per EU GMP Annex 1 (2022) and FDA guidance.
Know MoreAPI Manufacturing
PQ for API synthesis, crystallization, drying, and milling processes — particle size, yield, purity, and residual solvent acceptance criteria per ICH Q8/Q9/Q10 and FDA 21 CFR Part 211.
Know MoreLiquid & Semi-Solid Dose
PQ for oral liquid, topical cream, ointment, and gel manufacturing — homogeneity, viscosity, pH, microbial limits, and fill weight uniformity per EU GMP and Schedule M.
Know MoreMedical Devices
PQ for medical device manufacturing processes — dimensional validation, sterility process PQ, sealing process PQ — per ISO 13485, ISO 11135, and EU MDR 2017/745.
Know MoreBiotech & Biologics
PQ for bioreactor processes, purification, filtration, and fill-finish — process performance qualification (PPQ) per FDA Guidance for Industry (2011) and ICH Q8/Q9/Q10.
Know MoreNutraceutical & OTC Products
PQ for dietary supplement and OTC product manufacturing — blend uniformity, content uniformity, disintegration, and dissolution per FSSAI, GMP, and USP requirements.
Know MoreEquipment & Utility Systems
PQ for equipment and utility systems including purified water (PW), water for injection (WFI), clean steam, compressed air, and nitrogen — per WHO, ISPE, and EU GMP standards.
Know MoreWhy Choose Prism
Two Decades of GMP Validation.
Zero Audit Observations.
Since 2004, every PQ validation report by Prism has been accepted by USFDA, WHO GMP, EU GMP, GPCB, and NABH auditors without a single observation.
— STANDARDS & COMPLIANCE —
Standards We Follow for PQ Validation
EU GMP Annex 15 (2015)
Process validation & qualification
FDA PV Guidance (2011)
Process validation — 3-stage approach
ICH Q8 (R2)
Pharmaceutical development / QbD
ICH Q9 (R1)
Quality risk management
ICH Q10
Pharmaceutical quality systems / CPV
ISPE Baseline Guide Vol 5
Commissioning and qualification
Schedule M India (2023)
Indian GMP requirements
WHO TRS 961 (Annex 4)
WHO process validation supplement
EU GMP Annex 15 + FDA Process Validation Guidance (2011)
All PQ protocols and reports are authored per EU GMP Annex 15 and FDA Process Validation Guidance (2011). Statistical analysis (Cpk) and CPV setup included. Every report accepted in USFDA, WHO GMP, EU GMP, GPCB, and NABH audits.
500+
PQ Projects Done
0
Audit Observations
— REVALIDATION & LEGACY PRODUCTS —
PQ for Legacy Products & Process Changes
Marketed products without formal PQ documentation, site transfers, batch size changes, and equipment replacements all require revalidation PQ under EU GMP Annex 15. Prism conducts retrospective, concurrent, and prospective PQ for legacy and existing products.
Retrospective PQ
Review of 20–25 commercial batches to establish validated process baseline — per EU GMP Annex 15 and FDA guidance.
Fast Campaign Start
PQ protocol ready in 5–7 days. Execution can begin within 2 weeks of engagement — suitable for urgent regulatory deadlines.
CPV Linkage
Every PQ is linked to CPV / APQR — so process trending continues beyond PQ closure per ICH Q10 Stage 3.
Change Control Ready
PQ reports authored in change control format — directly usable as change control closure evidence for equipment or process changes.
Onsite Coverage
Serving All
of Gujarat
Validation engineers based in Ahmedabad cover the full Gujarat pharma and industrial 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 PQ Validation Clients Say
Prism conducted PQ for our sterile filling line — worst-case bracketing, 3 consecutive runs, full statistical analysis. The PQ report was accepted in USFDA pre-approval inspection without a single observation. Exceptional depth of documentation.
Our tableting line PQ was completed in under two weeks by Prism, including CPV protocol and Annex 15 compliant report. Process capability (Cpk) analysis was thorough. WHO GMP audit accepted the report immediately.
We engaged Prism for revalidation PQ after a batch size change. Full APQR-linked PQ with statistical trending. Prism's knowledge of EU GMP Annex 15 and FDA Process Validation Guidance (2011) is genuinely impressive. Five-year annual partnership.
Prism conducted PQ for our sterile filling line — worst-case bracketing, 3 consecutive runs, full statistical analysis. The PQ report was accepted in USFDA pre-approval inspection without a single observation. Exceptional depth of documentation.
Our tableting line PQ was completed in under two weeks by Prism, including CPV protocol and Annex 15 compliant report. Process capability (Cpk) analysis was thorough. WHO GMP audit accepted the report immediately.
We engaged Prism for revalidation PQ after a batch size change. Full APQR-linked PQ with statistical trending. Prism's knowledge of EU GMP Annex 15 and FDA Process Validation Guidance (2011) is genuinely impressive. Five-year annual partnership.
Prism conducted PQ for our sterile filling line — worst-case bracketing, 3 consecutive runs, full statistical analysis. The PQ report was accepted in USFDA pre-approval inspection without a single observation. Exceptional depth of documentation.
Our tableting line PQ was completed in under two weeks by Prism, including CPV protocol and Annex 15 compliant report. Process capability (Cpk) analysis was thorough. WHO GMP audit accepted the report immediately.
We engaged Prism for revalidation PQ after a batch size change. Full APQR-linked PQ with statistical trending. Prism's knowledge of EU GMP Annex 15 and FDA Process Validation Guidance (2011) is genuinely impressive. Five-year annual partnership.
Get In Touch
Request a Free Quote
Tell us your product type, dosage form, batch size, and validation trigger (new product, site transfer, batch size change). We respond within 2 hours.
— FAQ —
Performance Qualification — FAQ
Need PQ Validation in Gujarat?
Call or WhatsApp — we reply within the hour. Onsite across Gujarat, 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
Performance Qualification services are performed per EU GMP Annex 15 (2015), FDA Process Validation Guidance (2011), ICH Q8/Q9/Q10, WHO TRS 961, and Schedule M (2023). All instruments used are NABL calibrated under Certificate CC-2480 (ISO/IEC 17025:2017).