Core Services
Process & Cleaning Validation
Process validation lifecycle, gap analysis, cleaning validation, and swab recovery studies aligned to ICH Q7–Q12 and FDA guidance.
Practice Overview
QRC runs process and cleaning validation across the full lifecycle — stage 1 process design through continued process verification. Our specialists author master plans, execute swab and rinse recovery studies, build cleaning matrices, and deliver continued-verification dashboards that satisfy ICH Q7–Q12 and current FDA guidance.
Capabilities
- Process validation stages 1–3
- Cleaning validation strategy and execution
- Swab and rinse recovery studies
- Hold-time and campaign studies
- Continued process verification programs
- Sampling plans and acceptance criteria development
Resources We Provide
- Process validation engineers
- Cleaning validation specialists
- Recovery study analysts
- Technical writers for master plans and reports
- Continued process verification analysts
Delivery Capabilities
- Process validation master plans
- Stage 1–3 validation reports
- Cleaning validation matrices
- Recovery study reports
- Continued process verification dashboards
Engagement Models
- Dedicated validation and quality resources
- Project-based delivery teams
- Short-term specialists for critical initiatives
- Long-term staff augmentation
- Turnkey validation program teams
- Inspection-readiness and remediation squads
Core ServicesIndustries & Applications
This service is delivered to clients across pharmaceutical, medical device, biotechnology, and regulated manufacturing operations.
PharmaceuticalMedical DeviceBiotechnologyRegulated Manufacturing
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