Quality & Compliance

Quality You Can Trust

At RemedyRepack, quality is the foundation of everything we do. Every product is supported by robust quality systems, validated processes, and regulatory oversight designed to help ensure the safety, integrity, and traceability.

Beyond regulatory compliance, we continuously evaluate and improve our systems to maintain reliability our customers can trust.

Our Commitment

From incoming materials through final product release, every stage of production is supported by documented procedures, trained personnel, and independent quality oversight.

Regulatory Compliance

RemedyRepack operates in compliance with applicable federal and state regulations and maintains the registrations and accreditation necessary to support pharmaceutical repackaging operations.

• FDA Registered Facility
• DEA Registered Facility
• NABP Accredited Drug Distributor
• Current Good Manufacturing Practice (cGMP) compliance
• DSCSA-compliant product traceability

Comprehensive Quality Systems

Our quality management system procedures include

• Document Control
• Change Control
• Deviation Management
• Corrective and Preventive Action (CAPA)
• Risk Assessments
• Complaint Management
• Employee Training and Qualification
• Internal Audits
• Annual Product Reviews
• Continuous Improvement Programs

Validated Operations

Our manufacturing and packaging processes are supported through documented qualification and validation activities designed to ensure consistent performance and product quality.

These activities include:

• Equipment Qualification (IQ/OQ/PQ)
• Packaging Process Validation
• Cleaning Validation
• Environmental Monitoring
• Calibration and Preventive Maintenance Programs

Product Safety & Traceability

We package every product under controlled conditions to maintain product identity, lot traceability, and inventory accountability throughout the manufacturing process.

Our capabilities include:

• Lot Traceability
• Barcode Verification
• Label Verification
• Product Reconciliation
• Recall Support
• Inventory Control
• DSCSA Transaction Data Management

Specialized Manufacturing Facilities

RemedyRepack operates dedicated facilities for penicillin and cephalosporin products, with segregated equipment, personnel, and operational controls designed to minimize cross-contamination risk.

A Partner You Can Depend On

Healthcare organizations depend on consistent quality, service, and regulatory compliance. Our experienced Quality and Operations teams work together to deliver pharmaceutical packaging solutions that support patient safety, supply chain reliability, and long-term customer success.