Services

Qualification Services

Services

Qualification Services

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.

Facility Qualification in Pharmaceuticals

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.

Installation Qualification (IQ)

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.

Operational Qualification (OQ)

Consistency is key in biopharma manufacturing. Our OQ protocols verify that each component operates per manufacturing and process design requirements.

Performance Qualification (PQ)

We test equipment and system functionality in production conditions to ensure the product is manufactured consistently meeting safety, integrity, strength, purity, and quality requirements. Manufacture with confidence knowing biopharma’s qualification experts have thoroughly tested your equipment.

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)

Former Senior Director of Validation
Shire (now Takeda)

Shire (case study heading image)

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

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

How Can We Help You Get It Done Right?