Multi-product medicines manufacturer; TGA-regulated environment
After a TGA finding — multi-product medicines manufacturer
The challenge, in operational terms
A manufacturer with systems that had been in place for over twenty years. A recent TGA audit found major gaps in the rationale behind their controls. The staff couldn't understand why arrangements that had been accepted for years were suddenly non-compliant, QA and operations disagreed about how the controls should be implemented, and everyone was overwhelmed by the volume of work the findings had created.
What I did, including the assessment method
I reviewed the finding and every document covering the affected area, walked the facility to see where implementation actually differed from the procedure, and interviewed staff about what they understood and what was getting in their way.
What was delivered
The report set out each gap with a priority level and a proposed mitigation, and every finding came with the reasoning: why this specific thing would concern an inspector. That was followed with tailored training built from what the walkthrough and the interviews had found.
The result
The outcome was a prioritised plan, and QA and operations working from the same understanding of what was actually required, and why.
Related services
GxP Compliance Assessments
An honest, prioritised picture of where you stand against the regulations that apply to you. Includes preparing for an inspection, addressing findings after one, and identifying areas for improvement.
For: companies who suspect something isn't right but can't name it or size it.
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.
