Mozeka · Pharmaceutical quality · UK and EU GMP
Your microbiologist and quality specialist, without the headcount.
Quality consultancy and auditing for small pharmaceutical manufacturers, with contamination control at the core.
For start-ups and small pharmaceutical businesses with limited resources. I design contamination control into your quality system from day one, so it runs through the facility, the processes and the people rather than being bolted on after the first excursion.
Tamryn Hassel
Built for start-ups and small businesses with limited resources.
Most of my work is with companies that need a strong quality system but do not have a big team to build or run one: cell and gene therapy and biologics start-ups, virtual developers moving into their own facility, and small manufacturers going for a first licence or keeping one. You get the quality system a big company would build, sized for a team of five.
How I think about it
Contamination has eight ways in. One strategy closes them all.
Contamination does not come from one place, and it does not respect department boundaries. EU GMP Annex 1 expects sterile manufacturers to have a contamination control strategy that covers every route in, from suppliers to people to how you respond when something goes wrong. The same thinking protects any product. I build it as one connected system, not eight separate procedures.
01 / 08 · Route in
Premises and airflow
Where it gets inPressure cascades that drift, airflow that does not protect the critical zone, and surfaces that shed or cannot be cleaned.
What I build inGrades and zoning designed with the strategy from the start, airflow visualisation where it matters, and finishes chosen because they can be cleaned.
02 / 08 · Route in
Utilities
Where it gets inWater systems with dead legs and biofilm, compressed gases and steam that touch the product, and HVAC that slips out of maintenance.
What I build inEvery utility mapped into the risk assessment, sampling points and limits set by how each one is used, and maintenance tied to contamination risk.
03 / 08 · Route in
Equipment
Where it gets inEquipment that is hard to clean, sterilisation that has not been properly validated, and maintenance that breaks integrity.
What I build inDesign reviewed for cleanability before you buy, sterilisation validated, and maintenance planned around contamination risk.
04 / 08 · Route in
Suppliers and materials
Where it gets inRaw materials, components and container closures carrying bioburden, and outsourced sterilisation or testing nobody is overseeing.
What I build inRisk-based supplier qualification and audits, incoming material controls and bioburden limits, and quality agreements that say who controls what.
05 / 08 · Route in
The manufacturing process
Where it gets inOpen steps, transfers, hold times and interventions nobody planned for.
What I build inA process risk assessment, defined interventions tested in your process simulation, validated hold times and in-process bioburden controls.
06 / 08 · Route in
People
Where it gets inGowning, behaviour, movement, and the shortcut taken on a busy shift.
What I build inGowning qualification, aseptic behaviour training and flows designed so the right thing is the easy thing.
07 / 08 · Route in
Cleaning and disinfection
Where it gets inThe wrong agent, the wrong contact time, residues left behind, and no sporicide in the rotation.
What I build inAgents and contact times that are validated, sporicides used where they are needed, and a programme adjusted to what your EM data shows.
08 / 08 · Route in
Monitoring and response
Where it gets inMonitoring in the wrong places, data nobody trends, and excursions closed without a root cause.
What I build inAn EM programme located by risk, trending that is actually read, and investigations that find the root cause and CAPA that holds.
Tap a route, or watch them in turn.
Where are you right now?
Most clients come to me at one of five moments.
Each needs something different. Find yours and see what I would do first.
Free guide
Six settle plate mistakes that undermine your EM data
What goes wrong with passive air monitoring, and what good looks like. An 11-page practical guide, written by a pharmaceutical microbiologist.
A good place to start
Readiness Review
A fixed-price review of where your quality system stands against EU GMP, with contamination control looked at specifically. Remote, or with a day on site. You get a clear answer on what is ready, what is not, and what to fix first.
Not for you if you want a system signed off without anyone looking at it, or you need a QP to certify batches.
Remote review
From £1,950
Plus VAT where applicable.
Full review with a site visit from £4,500. Compare →
- ✓Remote review of your documents, systems and plans
- ✓Written gap report, prioritised by inspection risk
- ✓Contamination control looked at specifically
- ✓60-minute debrief call to walk through the findings
- ✓Two days of my time, start to finish
How Mozeka works
The Readiness Review is the easiest way in, not a requirement. If you already know you need an audit or help building your system, come straight to auditing or consultancy.
Consultancy
I build, review and remediate quality systems and contamination control strategies, from the first licence onwards.
Auditing
Supplier, contractor and self-inspection audits, delivered to one method and reported the same way every time.
Training
Tailored GMP, microbiology and contamination control training for quality and operations teams.
Readiness Review
A fixed-price review of where you stand before a licence application or inspection, with a prioritised action list.
From £1,950 remote, £4,500 with a site visit. Plus VAT where applicable. See what’s included →
Coming in 2027
The Subculture by Mozeka
A reference of pharma-relevant microorganisms that tells you what a recovery means for your facility.
The Mozekan
A club for start-ups building their first quality system: QMS Factory, training and Mozeka’s consultants when you need them.
Not sure where you stand?
Start with a Readiness Review, or read the free settle plate guide first.