Why GMP Is Non-Negotiable for Cell Therapy
Good Manufacturing Practice is the regulatory foundation for any cell therapy product intended for clinical use. Without GMP compliance, your product cannot enter clinical trials, cannot be licensed, and cannot reach patients.
GMP Compliance
- GMP gap assessment and roadmap
- EU GMP Annex 1 / Annex 2 compliance
- FDA 21 CFR Part 211 alignment
- Manufacturing process documentation
- Batch record design and review
- Change control and CAPA systems
ISO 13485 Quality Systems
- QMS design and implementation
- Document control system setup
- Internal audit programme
- Supplier qualification procedures
- Risk management (ISO 14971)
- ISO 13485 certification preparation
Process Improvement
- Six Sigma DMAIC methodology
- Process capability analysis
- Yield and consistency improvement
- Out-of-specification investigation
- Root cause analysis
- Continuous improvement programmes
Regulatory Frameworks We Work With
| Framework | Applies to | Our Support |
|---|---|---|
| EU GMP Annex 1 & 2 | Advanced Therapy Medicinal Products (ATMPs) — cell and gene therapies in the EU | Full compliance assessment, facility design review, documentation, batch record systems |
| FDA 21 CFR Part 211 | Drug products including biological therapies in the US market | US market entry strategy, IND support, facility and process alignment |
| ISO 13485:2016 | Medical devices and combination products with a device component | QMS design, gap assessment, certification support, internal audit programme |
| ICH Q10 | Pharmaceutical quality systems — internationally harmonised | Quality system design aligned to ICH Q10 lifecycle approach |
| ISO 10993 | Biocompatibility of medical devices and product components | Test plan design, study management, regulatory report writing |
| ISO 14971 | Risk management for medical devices | Risk management file development, FMEA, hazard analysis |
Our GMP Implementation Process
GMP Gap Assessment
We audit your current manufacturing environment, processes, and documentation against the applicable GMP standard. The output is a structured gap report with a prioritised remediation roadmap and implementation timeline.
Quality Management System Design
We design or overhaul your QMS — including document hierarchy, change control, deviation management, CAPA, and supplier qualification. Systems are built to be functional and proportionate, not just compliant on paper.
Process Validation
We design and oversee validation of your critical manufacturing processes — including cell expansion, harvest, formulation, fill/finish, and cryopreservation. Validation protocols and reports are written to regulatory standards.
Staff Training & Qualification
We develop and deliver GMP training programmes for your manufacturing and quality teams — covering principles, documentation standards, aseptic technique, and deviation management.
Mock Inspection & Regulatory Readiness
Before your first regulatory inspection, we conduct a comprehensive mock inspection — identifying vulnerabilities, coaching your team on inspector interactions, and ensuring your documentation is audit-ready.
Our consultants hold certified GMP, ISO 13485, and Six Sigma credentials. We have applied these frameworks in working biotech environments — not just read the guidelines.
Team Quality Credentials
Frequently Asked Questions
What is GMP and why does it matter for cell therapy?
Good Manufacturing Practice (GMP) is the set of regulatory standards governing medicines manufacturing. For cell therapies, GMP compliance is required before entering clinical trials or reaching patients.
What is the difference between GMP and ISO 13485?
GMP is a regulatory requirement for pharmaceutical and cell therapy manufacturers. ISO 13485 is a quality management standard for medical devices. Many cell therapy companies need both. We advise on the right combination for your product classification and target markets.
How long does GMP implementation take?
A basic GMP-compliant research environment can be established in 3–6 months. Full manufacturing readiness for a clinical-stage product typically takes 12–24 months. We start with a gap assessment to give you a realistic, phased roadmap.
Can you help us prepare for an EMA or FDA inspection?
Yes. We run mock inspections, review your documentation package, and prepare your team for regulatory interactions. We have experience with both EMA and FDA inspection frameworks for ATMP and biologics manufacturers.
Related Services
Start Your GMP Journey
Whether you are building from scratch or remediating an existing facility, our consultants will give you a clear picture of where you stand and how to get where you need to be.
Book a GMP Gap Assessment