Pharmaceutical Systems Validation
Services Available Nationwide
Our team of practiced experts has experience identifying areas for improvement in various strands of a variety of pharmaceutical companies. Our solutions are comprehensive and all-encompassing, covering Pharmacogenomics, Pharmacovigilance, Bio Informatics and laboratory informatics (LIMS) requirements. This end-to-end service ensures the effective running of industry development and ensures compliance with Federal and European regulations. Our validation services are around the UK enable companies to excel in productivity, efficacy and profit.
A complete list of our services is as follows:
Services Available Nationwide
Our team of practiced experts has experience identifying areas for improvement in various strands of a variety of pharmaceutical companies. Our solutions are comprehensive and all-encompassing, covering Pharmacogenomics, Pharmacovigilance, Bio Informatics and laboratory informatics (LIMS) requirements. This end-to-end service ensures the effective running of industry development and ensures compliance with Federal and European regulations. Our validation services are around the UK enable companies to excel in productivity, efficacy and profit.
This Service Includes :-
21 CFR Part 11 Compliance
Software Quality Assurance
Software Testing
System Support and Training
Audits and Assessments
Process Validation
Our service for process validation ensures that the processes set in place by your company consistently produce the desired outcomes – rendering products that meet requirements on quality and specification. This could include the analysis of manufacturing, packaging and sterilisation processes within the pharmaceutical industry.
Our validation services can be broken down into three sections:
Process Design :-
Our team will work with you to develop an understanding of the desired outcomes of the process in question, before developing said process, along with a strategy to ensure process control throughout.
Process Qualification :-
The process we have designed will then undergo thorough evaluation to ensure that the required outcomes are being met. We will also evaluate the ongoing reliability of the process as it pertains to efficient commercial manufacturing. We’ll repair a final report and take measures to ameliorate any imperfect elements.
Continued Process Verification :-
As routine production is carried out, ongoing verification will be performed, to ensure that the process is stable. We will undertake periodic assessments of the process also, to identify and undertake necessary alterations or recalibration of the process.
Cleaning Validation
Thanks to the expertise of our experienced staff, we can construct and execute master plans for cleaning development and cleaning validation. We begin with a hazard identification process and examine cleaning processes in-depth, to ensure that all potential hazards are identified and mitigated before they have the chance to exacerbate. This includes chemical and microbiological hazards, as well as API, cleaning agents and Micro/Endotoxins usage in your workplace
Services Available Nationwide
Validation Network offer validation services, ensuring that all utility and HVAC systems are qualified and in pristine working order. We will inspect your system thoroughly before qualifying it if it meets the required specifications. We can qualify brand-new systems, as well as issuing change control documents for the modification of existing systems. Our services are available on an independent basis or, alternatively, we are able to work with system vendors in the generation of specific relevant test documents and scripts.
Types of utilities that we validate include :-
Gas Systems (CO2, Nitrogen)
Electrical
Waste Disposal
HVAC Building Automation Systems
Steam Generation
Compressed Air
Storage Tank Systems
RO (Reverse Osmosis)
UF (Ultra Filtration)
PUR (Purified Water)
WFI (Water for Injection) Hot or Variable Temp
Loop Distribution Controls
Distillation Systems
Services Available Nationwide
By law, any and all equipment used in the storage, production, packaging or quality control testing of any cGMP product must submit to proper validation. This includes all electronic, mechanical or automatic equipment, which must be checked, inspected and, if necessary, recalibrated on a routine basis. This must be done in accordance with a specific written program, designed to ensure effective performance.
Our expert team are adept at providing validation services ( available nationwide) and specialise in the following types of equipment:
Analytical Lab Equipment :
- HPLC, UPLC, GC, LC-MS
- Spectrophotometers (UV/VIS, IR, FTIR)
- Protein Sequencers, Flow Cytometers, Micro Readers, Plate Readers
- Refrigerators, Freezers, Ovens, Incubators, Autoclaves
- MB Laminar Flow, Biosafety Cabinets
- Titrators, Dissolution, Stability Chambers
- Degassers, TOC Analyzers, dPCR and ddPCR
Software and DAS Systems :
- OpenLAB
- Millennium
- MassHunter
- Empower
- Chemstation
- Chemstore
- SoftMax Pro
- DSC
- SCADA
Manufacturing Equipment :
- Mixers, Dryers, Fluid Bed Dryers
- Tablet Presses, Sterilization Tunnels, Tanks and Vessels.
- Ampoule, Capsule, Syrup and Vial Fillers
- Cartooning, Coating and Labelling
- Cream and Ointment Filling
- Centrifuges and Bioreactors
- Chromatography
- Freeze Dryer
Sterilization :
- Dry Heat and Steam Sterilisers
- Terminal Sterilisers
- Isolators
- Gas Cycle Development
- Hydrogen Peroxide
- Gamma Radiation
- Steam or Sterilize in Place (SIP) or Clean in Place
Vision and Labelling Systems :
- Labelers
- Laser and Engraved Printing
- Automated Vision Systems
- Labelling and Inspection for HIBC and Barcodes
Packaging :
- Blister Packs
- Sealers and UDI Labelers
- Trayers, Checkweigher Machines, Cartoners, Case Formers and Tapers, Inkjets
- Inventory Recognition Systems (RFID)
Test Equipment :
- Dissolution Samplers
- Friability Testers
- Refractometers
- Powder Handling Equipment
