Validation Consultancy & Training
Paragon V offer validation consultancy and training where we are able to share our experience and offer practical solutions for the following
Validation lifecycle training
Application of risk based approach to validation
System impact assessment
FMEA


Capital Projects
Paragon V offers the following support for large and small projects for clients and vendors
Validation project lead
Vendor representative where vendor knowledge of the validation lifecycle is limited
Gap Analysis & Remediation
Paragon V offer support for Gap analysis and remediation where the validation lifecycle process needs to be reviewed.
Audit preparation
Responses
Remediation
Implementation


Qualification & Requalification
We specialise in Commissioning and Qualification across the Validation Lifecycle incorporating:
Assisting with URS / Vendor selection
FMEA
Validation Master Plan / Validation Plans
Design Qualification (DQ)
Requirements Traceability Matrix (RTM)
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Cycle Development
Performance Qualification (PQ)
Process Performance Qualification (PPQ)
Paragon V specialise in the following areas
Controlled Storage / Distribution Environments
- Controlled Storage Environments (CSE’s)
- Fridges
- Freezers
- Incubators
- Walk In Cold Rooms
- Warehouses / Controlled Ambient Storage
- Liquid Nitrogen Cryogenic Freezing
- Temperature Controlled Distribution
- Controlled Road Freight
- Controlled Sea Freight
- Active Sir Freight
- Passive Air Freight
- Cold Chain (2°C to 8°C)
- Controlled Ambient (15°C to 25°C)
- Frozen (-20°C and -40°C)
- Cryo Shipping (Liquid Nitrogen)
Sanitisation, Sterilisation and Depyrogenation
- Steam Sterilisation
- Autoclave (Porous and Fluid Loads)
- Steam In Place
- Steam Out of Place
- Depyrogenation
- Tunnel Steriliser
- Depyrogenation Oven
- Vaporised Hydrogen Peroxide (VHP)
- Gamma Irradiation
- Sterile and non-sterile pharma & biopharma
- Vial
- Pre-Filled Syringe
- Tubes
- Ampoules
- Blister Packaging
- Cryo Vials
- Media Simulations
- Upstream equipment
- Downstream equipment
- Cleanroom Facilities including HVAC
- Design
- Airflow Visualisation
- Installation and Operation Qualification
- In Use Performance Qualification
- On-Going Environmental Monitoring regime
We also have experience and offer support in the following Life Science Applications:
- Utilities
- WFI / Purified Water
- Clean Steam
- Process Gases (CO2, Nitrogen, Process Compressed Air)
- Various Formulation / Product types:
- Solid Dose
- Liquid
- Granule
- Powder
- Semi Solid (Ointment)
- Paste
- Tablets
- Medical Devices
- Lyophilisation
- Cleaning Validation
- Clean In Place (CIP)
- Clean Out of Place (COP)
- Parts Washer
- Secondary Packaging
- Inspection Vision Systems
- Process Performance Qualification (PPQ/CPV)
- Mixing Studies – Disposable and Fixed Systems
- Computer Systems Validation (CSV)
- Laboratory Equipment