Safety
Products pose no unacceptable risk
Quality
Terrain’s products safeguard patient health and deliver consistent therapeutic value - every batch, every time.
SISPQ Framework
Quality Systems & Regulatory Compliance
Quality by Design (QbD) woven into formulation work
Formal risk assessments (FMEA, hazard analyses) predict failure modes
Critical Quality Attributes (CQA) defined early with test plans
Traceable documentation links scientific rationale to every design choice
Full compliance with FDA 21 CFR Parts 210 & 211 and current cGMP
Alignment with USP, ICH Q guidelines, and ISO 9001 principles
DSCSA serialization for end-to-end traceability
HIPAA safeguards for any protected health informationHIPAA safeguards for any protected health information
Stability programs monitor quality over shelf life
Structured complaint handling and adverse-event reporting feed CAPA
Annual Product Quality Reviews (APQRs) and trend analytics
Continuous watch on evolving global regulations
Supplier Quality Management
Quality starts long before we press “start” on a batch.
Supplier Qualification
Material Qualification
Ongoing Monitoring
Supply-Chain Security
Continuous Improvement
Quality Metrics
Dashboards track right-first-time, deviation rates, complaints, audits; leadership reviews trigger action plans.
CAPA
Root-cause tools (5 Whys, Fishbone, Fault-Tree) drive fixes; verification confirms effectiveness.
Quality Culture
Ongoing training, open-door reporting, and recognition programs embed ownership across every function.
Certifications & Standards
