Qualification & Validation

Axiom Qualification and Validation provides a fully integrated approach to qualification of cGMP equipment, utilities, and controlled environments, in addition to validation of sterile or aseptic processes. The qualification and validation provides value added from day one of the project. This begins with identifying specific deliverables needed to ensure traceability and compliance with validation and functional requirements.

Our perspective during the design phase allows invaluable input on the ‘validate-ability’ of system, facility, or process. Once the system design and functionality is understood, a specific qualification and validation strategy can be implemented through qualification and validation project plan. The basic understanding of the system design allows for the team to use a tiered approach to testing which is more efficient and eliminates redundancy within the project life cycle. As a result, there is a seamless transition to cycle and process development. An optimized cycle and process allows for our clients and partners to utilize the best approach moving into active production. Axiom understands the importance of transparency and compliance with so much at stake with patients lives.

With a wide range of specialties in Active Pharmaceutical Ingredients or Drug Substance, Bulk Intermediates, OTC, Solid, and Liquid Dosage Forms, Biotechnology / Biologics, Nutraceuticals, Pharmaceuticals, Parentals, Clinical Manufacturing, Finishing / Packaging, Cosmetics, and Medical Devices, the following aspects are supported by Axiom Qualification and Validation:

Equipment Qualification:

  • SAT and FAT support
  • Startup and Commissioning
  • Equipment Verification
  • cGMP Utilities
  • GLP Laboratories and Instrumentation

Controlled Environments:

  • Clean Room Finishes
  • HEPA Certification
  • Room Air Changes
  • Air Pressurization
  • Building Management System

Automation:

  • 21CFR Part 11 Compliance
  • GAMP

Validation

  • Cycle Development
  • Filter Validation
  • Process Validation
  • Cleaning Validation
  • Computer Validation
  • Stability Testing

Project Life Cycle Documentation:

  • Validation Plan
  • Traceability Matrix
  • Final Configurations Specifications

Other Specialties:

  • Technology Transfers
  • Aseptic Processing
  • Sterilization Processing
  • Validation to EN Requirements
  • ASTM 2500

Our compliance standards fully meet and satisfy the following companies requirements:

  • EN 285
  • FDA- US Food and Drug Administration
  • EMEA- European Medicines Agency
  • PDA- Parenteral Drug Association
  • CFR – Code of Federal Regulations

Contact us for all of your qualification and validation needs. See our other services for program management, project engineering, regulatory & quality, and strategic sourcing.