Services
Supporting 503A & 503B compounding pharmacies with practical, engineering-driven solutions.
Tailored Support for Compounding Pharmacies
Pharmacy Solutions Consulting provides specialized regulatory, quality, and engineering expertise for sterile and non-sterile compounding operations. Our services help pharmacies improve compliance, strengthen their quality systems, validate critical equipment, and enhance operational performance—all with clear, actionable guidance your team can implement.
Whether you’re preparing for an inspection, building new systems, or optimizing your existing processes, we’re here to help.
Regulatory & Compliance Support
We help pharmacies interpret and implement USP <795>, <797>, <800>, cGMP expectations, and State Board requirements with confidence. Our support blends regulatory expertise with practical, real-world solutions that work for your specific operation and workflow.
How We Support You:
• USP chapter gap assessments
• 503A and 503B readiness assessments
• Mock inspections and internal audits
• Remediation plans for observations or citations
• SOP development and documentation overhaul
• FDA, State Board, and accreditation preparation
Outcome:
A more compliant, inspection-ready pharmacy with systems that support safety, accuracy, and quality.
Engineering & Validation Services
Engineering-driven support for critical equipment and systems ensures your pharmacy operates safely and consistently. We provide comprehensive qualification and validation services for sterile compounding equipment and processes.
Our Expertise Includes:
• Equipment Qualification (IQ/OQ/PQ)
• Depyrogenation validation and thermal mapping
• Sterilization validation (dry heat, moist heat)
• Cleanroom qualification support
• HVAC and pressure differential evaluation
• Airflow and engineering control assessments
• Environmental controls review and optimization
Outcome:
Defensible, audit-ready validation documentation and equipment performance you can trust.
Operational Optimization
We improve the flow, efficiency, and reliability of your compounding operation by analyzing facility layout, personnel movement, and process design.
We Help Optimize:
• Facility layout and engineering workflow
• Material and personnel flows
• Environmental control strategy
• Technician task sequencing
• Production efficiency and throughput
• Training and competency integration
• Risk reduction across processes
Outcome:
Safer, more efficient operations that reduce errors and support compliance.
Custom Consulting Engagements
Every pharmacy is unique. If your facility requires support outside the services listed above, we’re happy to customize a consulting engagement based on your needs.
Common custom projects include:
• New facility design review
• Expansion planning
• Corrective action implementation
• Technology or equipment transitions
• Post-inspection remediation
• Quality system rebuilds
Outcome:
Tailored solutions aligned with your goals, timelines, and regulatory expectations.
Ready to Strengthen Your Pharmacy?
We help compounding facilities operate with confidence through engineering, validation, and compliance expertise.