Comprehensive biopharma commissioning activities integrated with expert IQ, OQ, and PQ services ensure all facilities, systems, utilities, and equipment meet design requirements and are verified as ‘fit for intended use’ with appropriate documentation resulting in efficient and cost-effective approvals.
ICQ follows the latest best practices outlined by the FDA, EMA, ICH, WHO, ISPE, PDA, ISO, and dozens of other global regulatory agencies to ensure your project meets all regulatory requirements while adhering to your company’s site-specific procedures and policies.
ICQ in Action
Expertise and the staff to implement.
“ICQ was instrumental in the development of our CQV and AIQ programs, from providing leadership and guidance…to the actual generation of standard operating procedures.”
Former Senior Director of Validation
Shire (now Takeda)
We have honed our IQ processes over more than a decade of expertise building out manufacturing facilities, including equipment, utilities, and computer systems. Our risk-based processes ensure more efficient and compliant greenfield and brownfield buildouts while limiting the need for future changes.
Life Sciences Qualification Services
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Analytical Instrument Qualification (AIQ)
- Quality Systems and Remediation Services
- Requalification
- Project Planning and Execution
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Analytical Instrument Qualification (AIQ)
- Quality Systems and Remediation Services
- Requalification
- Project Planning and Execution