Commissioning, Qualification, and Validation (CQV) 

Your CQV Needs

Kymanox caters to your specific needs to get CGXP commissioning and validation done. Key subject areas include process, cleaning, analytical methods, facilities, clean utilities, equipment, methods, computer systems, and environmental chambers.

  • Scope, timelines, and budgets are actively managed to meet your requirements.
  • Safety is always the first priority and all commissioning is supervised by a licensed Professional Engineer (PE).
  • Our expertise in factory-based qualifications support compressed start-up schedules.
  • Extensive design experience facilitates required technical understanding
  • A single-point of contact Technical Project Manager is assigned to your project with oversight from our Project Management Office (PMO).
  • ISPE’s GAMP V-model is fully leveraged and all validations are based on approved, testable requirements.

 

Your Regulatory Requirements

Kymanox knows how to comply with the regulations issued by governmental agencies (e.g., FDA, EMA, Health Canada) and how to make the most of industry guidance issued by both governmental and non-governmental bodies (e.g., ISPE, ISO, ICH, WHO):

  • Kymanox knows what regulations apply to you
  • Kymanox understands how to interpret the regulations and available guidance
  • Experienced in biotechnology, pharmaceuticals, and medical devices

 

Your Documentation

Kymanox knows that documentation is everything and is as important as the quality of executed work.  Our documents will stand as monuments and be leverageable for the business.  Documents we prepare and execute include:

  • Validation Project Plans, Validation Master Plans (VMPs)
  • User Requirements (URS), Functional Requirements (FRS)
  • Policies, Standard Operating Procedures (SOPs), and Forms
  • Factory and Site Acceptance Testing (FAT/SAT)
  • Work Instructions, Master Batch Records
  • Turnover Packages (TOPs), Design Review
  • Commissioning Protocols, Validation Protocols (DQ/IQ/OQ/PQ), Final Reports

 

Our proven past performance includes:

  • EQUIPMENT
  • Custom, Automated Process Equipment (All types, e.g., reel-to-reel processing lines)
  • Lyophilizers
  • Automated Filling Lines (e.g., Vial, Syringe, Aerosol, Blow/Fill/Seal)
  • Autoclaves, Ovens
  • Refrigerators, Freezers, Ultra-low Temperature Freezers
  • Controlled Humidity Chambers/Rooms, Stability Chambers, Incubators
  • Liquid Chromatography Skids and Columns
  • Compounding Vessels, Buffer Prep Vessels
  • FACILITY
  • Cleanrooms (ISO 5, 6, 7, and 8)
  • Laminar Airflow Hoods, Bio-Safety Cabinets
  • Building Management Systems (BMS)
  • Storage, Warehouses
  • UTILITIES
  • USP Water/WFI Skids and Distribution Systems
  • CIP/SIP Skids
  • Clean Process Gasses
  • CLEANING
  • Fermentation and Cell Culture Vessels
  • Aseptic Process Equipment
  • Medical Devices
  • METHODS (ICH Q2 (R1)) 
  • Rapid sterility
  • Raw material release
  • In-process and final product release testing
  • Complex and novel bioassays
  • COMPUTER SYSTEMS
  • Cloud-based, app-based
  • REMS Management Systems
  • ERP (SAP, Sage, Microsoft Dynamics, NetSuite)
  • PLC, HMI, SCADA
  • Document and Quality Management Systems 
  • Maintenance and Calibration