GxP Consulting
Sterile / Aseptic Manufacturing
Trusted Partner
With over 15 years of specialist experience working directly with the world’s leading Sterile and Aseptic manufacturers, i-Pharm GxP has built a reputation for trust and long-term value.
We have a deep understanding of cutting-edge technologies that offer accelerated gains in sterile-injectable production, proven expertise in implementing the latest intelligent systems that provide real-time analysis and data to better inform decision-making, and a firm grasp of the nuances of the modern regulatory landscape for sterile/aseptic therapeutics.
Our Technical Capabilities
We scope, staff, manage, and deliver business-critical project initiatives that underpin compliant and efficient manufacturing operations across the following areas.
Quality Assurance
- Root Cause Investigation Analysis and Corrective & Preventative Action (CAPA) design and delivery
- Quality Operations Oversight & continuous manufacturing support
- Supplier Quality Audit & Assessment
- QMS Assessment, Development & Optimisation
- Hypercare/Hypervigilance services (CMO/CDMO oversight)
- Lean Six Sigma, DMAIC, fishbone, 5-whys methodologies, ISO 9001 & GEMBA/process walk-downs
Quality Control
- Microbiology & Immunology Support
- Lab Event Workflow Analysis
- Assay Development & Testing
- Analytical Instrument Audits
- Environmental Monitoring
Audit & Remediation Services
- Inspection Readiness
- Mock Audits/ Audit Preparation
- Pre-Approval Inspections (PAI)
- Remediation Services
- Audits of Critical Utilities, Laboratories, Manufacturing/Production facilities, and Warehousing/storage areas
- Gap Analysis and Priority/Impact Action Plans
- Working experience supporting Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, PMDA
Commissioning, Qualification and Validation Engineering
- Commissioning, Qualification, and Verification Services
- Computer Systems, Process and Equipment Validation
- Facilities Engineering
- Process Engineering
- IQ, OQ, PQ
- HVAC/facilities, smoke studies, air balancing, temperature mapping, environmental monitoring
Computer & Control Systems
End-user optimization/harmonization, training, development, and implementation services for:
- QMS (Trackwise, eQMS, MasterControl, etc.)
- LIMS
- RIMS
- Labware
- MasterData
- KNEAT
- Netsuite
- Oracle ERP Cloud
- Johnson Controls, GE Digital, Siemens, Honeywell, Emerson Systems
AI / Machine Learning
- Automation System implementation and optimization services (Metasys, Rockwell, etc.)
- Bioinformatics and pipeline buildouts through machine learning deployment and architecture building
- Data Cleansing
- Cloud Migration
- Data and infrastructure scaling and buildout
Technical Writing / Medical Writing
- Technical documentation authoring, review, editing, and approval – SOPs, Work Instructions, Batch Record Review, etc.
- Grant writing, scientific writing, editing/copy editing. Regulatory documentation, SOPs, CERs, CSRs, MDD/MDR, Submissions
- Writing protocols, clinical study reports, investigator brochures, and IND components
Construction
- GMP Construction Management
- Construction quality management
- Contractor and vendor management (Owner’s Representative)
- Construction and vendor turnover package (CTOP/VTOP) planning and execution
Project Management & PMO
- Capital project management from concept to handover
- Cost engineering, scheduling, and risk management
- Integrated master scheduling across construction, CQV, and operations
- Governance, reporting, and stakeholder management
- Change control, forecasting, and project controls
Patient-first Approach
i-Pharm GxP takes a patient-first approach, recognising that our responsibility as an external consultancy goes beyond project delivery. Through knowledge transfer, cultural change, and lessons learned, we help embed sustainable practices that outlast our project teams and validated improvements.
This people-led approach underpins our commitment to developing behaviours and ways of working that protect patient safety long after we leave the site.
Flexible Networks
From cleanrooms and flexible fill-finish lines to laboratories and clean and black utilities, we support clients in the compliant, efficient manufacture of sterile and aseptic products such as vaccines, liquid and semi-solid formulations, APIs, and parenterals to patients worldwide.
Our flexible delivery model supports both capacity and capability challenges through a trusted network of industry experts.
