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Is Your Environmental Monitoring System Audit-Ready?
Be first in line. Register your interest.
Testo and PharmOut are opening applications for a limited amount of complimentary, on-site GxP Temperature Mapping Gap Analyses led by industry expert Ashley Isbel.
What you get
An independent set of expert eyes on your temperature-controlled storage.
This is not a sales call. A PharmOut GMP consultant walks your site, runs a structured gap analysis against current regulatory expectations, and delivers a clear report you can act on.
Onsite walkthrough
Visual inspection of controlled areas and environmental controls review, equipment and storage layout, monitoring devices, calibration, and operational practices.
A clear, actionable report
A summary report covering gaps, risks, and practical recommendations. Written so you can present it to your General Manager.
Why register
The compliance bar moved. Most facilities
have not checked against it.
Three forces have raised regulator expectations on temperature-controlled storage in 2026
Which was adopted by the TGA on September 1st 2025. Documentation requirements for storage conditions, Annex 15 qualification, and Chapter 3 expectations are tighter than the version most sites were last checked against.
Biotech and clinical trial sponsors are being asked to demonstrate fit-for-purpose environmental controls. Storage is a fast follower of trial inspections.
Monitoring records alone no longer satisfy auditors at IVF, blood and tissue, and biobanking facilities. They want to see the mapping that justified your sensor placement.
PharmOut. One of Australia's
most experienced GMP consultancies.
PharmOut has been working with TGA-regulated companies since 2006. Their consultants include chemical engineers, validation specialists, and GMP auditors. Testo trusts them. So do regulators.
Led by Ashley Isbel
Lead Consultant. GMP Services Director, PharmOut.
Among Australia's leading experts in sterile compliance and validation. Twenty-five years of practical experience as a qualified chemical engineer in GMP-regulated industries, including pharmaceuticals, pharmacies, medical devices, and blood and tissue.
Ashley routinely conducts practical gap analyses, design reviews, and inspections to help companies build compliance road maps. He has trained regulatory agencies and supported start-ups through CFR 820, CFR Part 11, PIC/S, ISO 13485, and 14644.
What is included in our gap analysis?
Every gap analysis covers the same scope. PharmOut tailors the depth based on your facility type during pre-engagement.
Doors, seals, insulation, airlocks, and identification of every temperature-controlled zone.
Racking, shelving, product placement relative to airflow, proximity to heat sources.
Door opening frequency, loading and unloading, contingency measures for power and HVAC failures.
Air handling units, ducting, diffusers, return vents, zoning, and segregation.
Sensor placement, data loggers, calibration stickers, and certificates.
Findings against PIC/S PE009 and WHO TRS 961, with practical next steps and a prioritised action list.