Fix the system,
not the symptom.
When the same compliance issues keep coming back, the problem usually isn't the finding. It's the system underneath it.
I help pharmaceutical manufacturers, sponsors and clinical research organisations build compliant quality systems their people actually use, and remove the complexity that was getting in the way.
Credentials.
28 years in pharmaceutical and life sciences quality
Three continents — Australia, Europe and Asia
Chair, Women in Pharma, ISPE Australasia Affiliate
Experience with USFDA, TGA and MHRA audits
Quality systems get heavier over time.
It happens to well-run companies
as reliably as to inefficiently run ones.
Every finding adds a control. Nothing ever gets removed. Each addition made sense to whoever made it. After a few years you have a system that produces non-compliance instead of demonstrating it, staffed by people who are all trying hard.
I was doing a facility assessment recently and found operators weren't replacing a dirty mat outside a processing room. Every mat change had to be logged, and they were moving in and out constantly, so the logging just added time without adding value. The mats stayed down.
They became a source of contamination rather than a control against it. No regulation requires that log, only evidence that the mats don't add contamination. Nobody knew why it existed. A control added to improve compliance was the reason compliance had failed.
That's the pattern,
and it's why I work the way I do.
What I do.
Design and implementation of tailored quality systems
Build a system that fits how you actually work, or fix one that doesn't.
GxP compliance assessments
Find out where you stand, ranked by risk. Before an inspection, after findings, or to identify areas for improvement.
Data integrity assessments
Whether your records would hold up. Paper, hybrid or electronic.
Audit support
Independent internal audits, and vendor audits for companies without the resource to manage them.
Who I work with.
How I work.
1. Customise.
Understand the operation and the applicable regulations before changing anything.
2. Simplify.
Take out what isn't doing any work, or isn't compliant.
3. Comply.
Implement, then verify what's left against the requirements.
The order matters.
You can't simplify something you don't understand, and you can't claim compliance for a system nobody uses.
Recent work.
After a TGA finding — multi-product medicines manufacturer
Systems in place for twenty years, a regulator questioning the rationale behind them, and staff unable to understand why.
A quality system built for Phase 1 — biotech CDMO
Moving out of R&D with no internal QA, a scientific team new to regulatory and quality process, and a limited budget.
A quality management system for a CRO — Melbourne
Process mapping and role definition through to creation of a quality manual, SOP framework, governance and staff coaching.
Insights.
Regulatory change, and what it means in practice.
The Why, What and How of going digital
Everyone working in the pharmaceutical and life science industry has heard of the digital revolution.
The hidden factory impacting regulatory compliance and quality
The challenges behind compliance can be amplified by supply chain, workforce and productivity pressures.
The Path to Quality Maturity: Strategic Training for Lasting Impact
Training is often treated as a compliance tick box rather than a way to change practice.
Who you'd be working with.
I'm Antiksha Joshi. I've spent 28 years in pharmaceutical and life sciences quality across three continents. I am Chair of Women in Pharma, ISPE Australasia Affiliate.
I also write and speak on quality systems for various knowledge sharing organisations and online publications.
My background is in microbiology, and I hold a diploma
in counselling, which sounds like an odd combination until you've watched a technically sound quality system fail because nobody could be persuaded to use it.
Whoever you speak to on the call is the person
who does the work.
Start with a conversation.
Thirty minutes on your situation, and an honest view on whether I'm the right person for it. Nothing to prepare.