Facilities & Equipment Qualification

Facilities and equipment qualification confirm that manufacturing and laboratory environments meet design specifications and regulatory expectations. Qualification activities support GMP compliance and ensure systems operate reliably and reproducibly.

Engineering qualification activities typically address cleanrooms, utilities, manufacturing equipment, and laboratory systems. Proper qualification reduces operational risk and supports consistent product quality.

Effective qualification programs are aligned with risk-based approaches and integrated into ongoing facility lifecycle management.

Facilities and equipment qualification commonly includes:

• Facility and utility qualification

• Equipment installation and operational verification

• Environmental control system qualification

• Ongoing requalification and maintenance support

• Documentation readiness for inspection