What is GMP remediation?
Learn what UK GMP remediation involves, from immediate risk control and root-cause analysis to governed CAPA, effectiveness checks and sustainable recovery.
Read the guideIndependent GMP consultants • UKGMP consultancy
GMP consultancy
for new builds and remediation.
From your first design decisions to a difficult inspection outcome, we work alongside your team. Practical GMP advice and hands-on support to help you move forward with a clear plan.
Facility design & qualificationInspection readiness & recoveryOperational GMP & quality
Where we workPharmaceutical manufacturingNHS aseptic servicesNew facilities & existing operations
Start with your challenge
Whatever your starting point, we can help.
Planning a new facility or working through compliance concerns? We’ll help you understand the priorities, challenge the evidence and put a practical plan in place.
New builds, upgrades & refurbishments
Get the GMP decisions right, early.
Integrate operational requirements, contamination control and qualification into the design before changes become difficult.
Explore new build support
Inspection findings & compliance recoveryBuild a defensible route to improvement.
Understand the risks, challenge the causes and govern a remediation programme with measurable evidence of progress.
Explore remediation support
Our expertise
Support across the GMP facility lifecycle.
Focused reviews or connected workstreams, agreed around your process, project stage and regulatory context.
01
New builds & cleanroom design
GMP input from concept and layout review through URS, design qualification and construction.
02GMP inspection remediation
Risk assessment, root-cause challenge, CAPA and a governed route to compliance recovery.
03Validation & qualification
Lifecycle strategy and evidence from DQ through IQ, OQ and PQ.
04Contamination Control Strategy
Connect facility, process, monitoring and operational controls around the actual risks.
05Quality systems & operational GMP
Strengthen documentation, investigations, change control and management oversight.
06Data integrity & computerised systems
Practical review of data governance, computerised systems and lifecycle controls.
How we workTechnical depth.
Technical depth.
Operational understanding.
We work with your people, your process and your priorities. Whether you need an independent view or ongoing support, our advice has to work in practice as well as on paper.
- 01
Understand the process
Clarify the intended use, product risk, site controls and decisions that need to be made.
- 02
Challenge the evidence
Review the design, records and assumptions. Make gaps and priorities visible.
- 03
Support delivery
Agree usable outputs, owners and review points within your governance.
Meet the people behind W2
Production and Quality experience, at the same table.
Kyle Winn and Adam Walker lead W2, bringing experience across sterile manufacturing, cleanroom projects, qualification and quality systems.
Our wider team adds expertise in aseptic operations, computerised systems, training and project coordination.
Meet the W2 team
The GxP Knowledge Centre
Clear answers to difficult GMP questions.
Practical explanations from the W2 library, with links between the principles and the decisions teams face.
What is operational readiness in GMP?
Learn what operational readiness means in GMP, including procedures, training, qualification, staffing, records, CCS and inspection readiness.
Read the guideWhen should you contact a GMP consultant?
UK: See when to contact a GMP consultant for inspection readiness, remediation, sterile operations, data integrity, major changes and independent assurance.
Read the guideBefore we start
A clear basis for working together.
When should we bring W2 into a new facility project?
Early input is useful while the intended use, layout and equipment requirements are being developed. We can also join at detailed design, qualification planning or operational readiness to review gaps and agree practical next steps.
Can you support a difficult inspection outcome?
Yes. W2 can review findings, support risk assessment, challenge root cause and CAPA, help structure the response and provide remediation governance. The client retains responsibility for its formal decisions and regulatory submissions.
Do you work with existing facilities as well as new builds?
Yes. Support can cover upgrades, refurbishment, process changes, contamination control, quality system improvement and routine operational GMP.
What happens in an initial discussion?
We establish the facility and process, the issue or project stage, the evidence available and the support you need. We then agree a defined scope and suitable outputs.
Help Me GxP · Sponsored by W2
Free learning for the work ahead.
Explore selected Help Me GxP lessons alongside your facility, qualification and quality-system planning.
Help Me GxP is co-created and run by Adam Walker and Kyle Winn, directors of W2 Cleanroom Consulting. W2 is the channel sponsor.
GMP foundations · 11:55
What is Good Manufacturing Practice?
Start with the principles of Good Manufacturing Practice and the questions behind day-to-day pharmaceutical quality.
Watch the lesson
Quality systems · 5:53
What is a pharmaceutical QMS?
Explore pharmaceutical quality management alongside the procedures, responsibilities and records used in your own operation.
Watch the lesson
Validation & qualification · 4:19
Validation: DQ, IQ, OQ and PQ
An introduction to qualification and validation terminology, to accompany your reading on the facility and system lifecycle.
Watch the lessonYou don’t have to work it out alone.
Tell us what you are planning or working through. We’ll help you make sense of the next step and agree where we can support your team.