Pharmaceutical Validation, Qualification and GMP Calibration
One accredited partner for your entire GMP compliance cycle — instrument calibration, equipment qualification and process validation, with documentation your auditor can sign off the first time.
DQ → IQ → OQ → PQ
A complete, defensible qualification package for every critical machine in your plant.
Design Qualification
Design reviewed against your URS and GMP requirements before the machine arrives on site.
Installation Qualification
Installation, utilities, drawings, materials of construction and documents verified and recorded.
Operational Qualification
Performance tested across the full operating range, including alarms, interlocks and worst-case settings.
Performance Qualification
Proven with your product, your load and your batch, over the required number of consecutive runs.
Equipment We Qualify and Validate
Autoclave & Sterilizer
Heat distribution, heat penetration, F0 value, biological indicator challenge, vacuum leak and Bowie-Dick tests.
Dry Heat Oven & DHS Tunnel
Depyrogenation FH study, 3-log endotoxin challenge, belt speed verification, empty and loaded chamber mapping.
LAF, BSC & Sampling Booth
HEPA filter integrity by PAO/DOP, air velocity, non-viable particle count, containment and recovery testing.
Stability Chamber & Incubator
Temperature and relative humidity uniformity, 24–72 hour mapping, alarm verification and power-failure recovery.
Cold Room, Chiller & Freezer
Mapping at +2 to +8 °C, −20 °C and −80 °C, door-open study and fixed sensor placement report.
Production & QC Equipment
Tablet press, blister machine, capsule filler, coater, FBD, RMG, dissolution apparatus and QC laboratory instruments.
What You Receive
- Approved protocol before work starts — no surprises at review
- ISO/IEC 17025 accredited calibration certificates for every sensor used
- Complete raw data, graphs and statistical summary
- Measurement uncertainty stated on every result
- Deviation notes with corrective recommendations
- Signed summary report, ready to file for audit
The Standards Your Auditor Uses
US-FDAISO/IEC 17025:2017ISO 14644
ISO 8573EN 28521 CFR Part 11 ready data
Also required for your GMP file: thermal mapping, compressed air and cleanroom validation and routine instrument calibration.
Frequently Asked Questions
What is the difference between calibration, qualification and validation?
Calibration compares an instrument against a traceable standard. Qualification (DQ, IQ, OQ, PQ) documents that a piece of equipment is designed, installed, operating and performing as intended. Validation demonstrates that the overall process consistently produces a result meeting predetermined specifications.
Do you perform autoclave and dry heat oven validation?
Yes. We perform heat distribution and heat penetration studies with F0 calculation for autoclaves, and depyrogenation FH studies with endotoxin challenge for dry heat ovens and sterilising tunnels, in both empty and loaded chamber conditions.
Is your documentation acceptable to DGDA and WHO-GMP auditors?
Our protocols and reports are prepared in the format GMP auditors expect: approved protocol, raw data, calibrated sensor certificates, deviation handling, summary report and conclusion. They are used by customers in DGDA, WHO-GMP, EU-GMP and US-FDA inspections.
Can you re-qualify equipment on an annual basis?
Yes. We run annual and periodic re-qualification programmes for autoclaves, ovens, LAF units, chambers, cold rooms and HVAC systems, and remind you before the due date.