Qualified Person (QP) Services
Facility Set up
Vendor Management/ Audits
Facility Set up
Expertise in the set up of the following facilities:
- WDA (H)
- MIA
- MIA (IMP)
- MS
Including:
- Cold chain products
- Controlled Drugs
Brexit Support
Vendor Management/ Audits
Facility Set up
- Support with clinical trial products and commercial products
- A dedicated Qualified Person (QP) providing Project Management and supply chain support
- Services available in the UK, Northern Ireland, Ireland and Netherlands
- Regulatory support as required
Vendor Management/ Audits
Vendor Management/ Audits
Vendor Management/ Audits
- Support for both clinical trial products and commercial products
- Active Pharmaceutical Ingredients (API) audits, performed by a EU Qualified Person (QP)
- Excipient manufacturers
- Packaging vendors
- Contract Manufacturing Organisations (CMOs); including sterile and non-sterile facilities
- Storage & Distribution facilities
Routine QA/ QP Support
Quality Management System
Vendor Management/ Audits
- Batch review
- Deviation investigation support
- Change management
- Technology transfers
- Generation of templates, e.g. Technical Agreements
- QA/ QP review of Technical Agreements
- Vendor Management schedules
- Ad-hoc QP support e.g. Recalls
Quality Management System
Quality Management System
Quality Management System
- GAP assessments
- Support with new or impending regulatory updates
- Development of a Quality Management System, bespoke to your needs
- Development of Site Master Files (SMFs) and Quality Manuals (QMs)
- Development of Standard Operating Procedures (SOPs)
- Performing internal audits/ self-inspections
- Performing 'mock' regulatory inspections, or support in the inspection readiness process