GxP Consulting
Sterile / Aseptic Manufacturing
Trusted Partner
With a 12-year history of working directly with the world’s leading Sterile and Aseptic Manufacturers as a specialist, i-Pharm GxP has a reputation for both trust and long-term value.
We have a deep understanding of the cutting-edge new technologies that offer accelerated sterile-injectable production gains, proven expertise implementing the latest intelligent systems that provide real-time analysis and data to better inform decision-making; and a firm grasp on the nuances of the modern regulatory landscape for sterile/aseptic therapeutics.
Our Technical Capabilities
We scope, staff, manage and deliver business-critical project initiatives for clients with capabilities in the following areas.
Quality Assurance
- Root Cause Investigation and Corrective & Preventative Action Design and Delivery
- Quality Operations Oversight & Continuous Manufacturing support
- DMAIC, RCA, GEMBA / process walk-downs, 5-whys, fishbone methodologies
Quality Control
- Environmental Monitoring
- Clean Rooms design and engineering for laboratory and manufacturing facilities
- Microbiology/Immunology
- Assay Development and Testing
QMS Assessment, Development and Optimisation
- eQMS, Trackwise, MasterControl
- ISO 9001
- Six Sigma
- Gap Analysis, Risk Matrix and prioritised impact/action plans
Commissioning, Qualification and Validation Engineering
- Computer Systems, Process and Equipment
- Facilities Engineering
- All aspects of aseptic processing and sterile injectable production.
- IQ, OQ, PQ
- HVAC/facilities, smoke studies, air balancing, temperature mapping, environmental monitoring
Regulatory Submission Preparation
- BLA – Biological License Applications
- Working experience supporting Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, PMDA
Inspection Readiness
- PAI
- Audits of Critical Utilities, Laboratories, Manufacturing/Production facilities and Warehousing/storage areas.
- Gap Analysis and Priority/Impact action plan
Audit Response & Remediation
- Across the Biotech, Pharma and Medical Device Industries (GLP, GCP, GMP, GxP)
- Working experience supporting Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, PMDA
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
AI / Machine Learning
- Data and Infrastructure scaling and build out
- Bioinformatics and pipeline buildouts thru machine learning deployment and architecture building.
- Data cleaning and data migration to the cloud. Ensuring proprietary data is cleaned, easily accessible, and can be fed into the ML model and algorithm.
Patient-first Approach
i-Pharm GxP works with a patient-first approach and an understanding that, as an external consultancy, we must have a commitment to delivering holistic cultural change and ensuring knowledge transfer and lessons learnt beyond our project teams and the revamped SOPs and engineering upgrades that we validate.
Working with people to foster understanding and develop the day-to-day behaviours and practices that outlast our physical presence and ensure patient safety is a key motivator behind our every engagement.
Flexible Networks
From Clean Rooms to Flexible Fill-Finish lines and from Laboratories to Clean and Black Utilities we partner with clients to enable the compliant, efficient manufacture of regulated sterile/aseptic products such as Vaccines, liquid/semi-solids, APIs, and Parenteral products to patients around the world.
Whether you have capacity or capability challenges, our services can be relied upon to provide you with a flexible network of industry experts.
