The Importance of Validation & Certification

The aim of validation, qualification and verification is to proof that facility, system and equipment fit its intended purpose. Validation, qualification and verification documentation is a written documentation to proof that the facility, system and equipment comply with pre-defined requirements represented as Critical Process Parameters and Critical Process Attributes.

We perform following validation processes:

  1. Risk assessment
  2. Definition of CPP (Critical Process Parameter) and CQA (Critical Quality Attribute) critical parameters
  3. URS (User Requirement Specification)
  4. VMP (Validation Master Plan)
  5. DQ (Design Qualification)
  6. FAT (Factory Acceptance Test)
  7. SAT (Site Acceptance Test)
  8. IQ (Installation Qualification)
  9. OQ (Operational Qualification)
  10. PQ (Process Qualification)
  11. PV (Process Validation)
  12. CV (Cleaning Validation)
  13. Validation of Packaging
  14. Verification of Transportation
  15. Ongoing Process Verification during Lifecycle

We perform qualifications and validations of following systems and equipment:

  1. HVAC systems
    1.  Cleanrooms
    2. Laminar and Biohazard Boxes, Izolators, RABs
  2. Systems
    1. Water for injection (WFI), Purified water (PW)
    2. Pure Steam (PS,CS)
    3. Compressed air (CA) and other clean gases (N2)
  3. Systems and equipment for sterilization
    1. Steam sterilizators
    2. Heat sterilizators, sterilization tunnels
    3. Chemical sterilizators (VHP, ethylenoxid)
  4. Production Facilities
    1. Dryers (fluid dryers, tunnel dryers, drum dryers)
    2. Dishwashers, dishwasher tunnels
    3. Process equipment
    4. Formulation tanks
    5. and many others
  5. Storage systems (according to GDP requirements)
    1. Warehouses
    2. Storerooms, boxes
  6. Cooling and freezing equipment (Cold Chain Management)

We perform validations also for computerized systems in various stages:

  1. Process control systems
  2. Monitoring systems
  3. Electronical signatures