Below are the standards we follow to ensure quality across all operations. All of our six facilities have dedicated quality staff, who report to our quality team at our headquarters.
Core Quality Practices
Document and Records Control: Systematic management of quality documentation, including Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Change Control and Deviation Management: Strict protocols for managing changes to processes, equipment, or systems to ensure compliance and minimize risks.
Nonconformance and CAPA: Comprehensive system to identify, document, and resolve nonconformances through Corrective and Preventive Actions (CAPA).
Product Traceability and Control: Robust traceability systems, including lot and serial number tracking, to ensure accurate product oversight and prevent the mixing of nonconforming and conforming goods. They also provide support for customer-initiated quality changes through documented recall procedures, SOPs, and comprehensive training programs.
Operational Quality Practices
Receiving and Inspection: Thorough inspection of incoming materials to ensure compliance with quality standards.
Quarantine and Nonconformance Areas: Designated areas for isolating noncompliant materials to prevent contamination or misuse.
Product Preservation: Practices for secure handling, packaging, and storage to maintain product integrity.
Process Monitoring and Improvement
Internal Audits: Regular audits to assess and improve the effectiveness of quality systems.
Training and Competency: Comprehensive training programs to ensure all personnel are skilled and knowledgeable about quality requirements.
Performance Monitoring: Use of metrics and monitoring systems to evaluate process efficiency and identify improvement areas.
Data Integrity Practices
Document Control: Comprehensive procedures for managing quality-related documentation to ensure accurate, secure, and authorized access. Includes systems for Change Control, Deviation Management, and Nonconformance Handling.
Validation of Computerized Systems: Regular validation processes for systems like ERP (Enterprise Resource Planning), labeling systems, and the eFactory portal to ensure data accuracy and reliability. Validation also addresses electronic change control systems to ensure the integrity of digital records.
Records Control: Detailed practices to ensure records are maintained securely, accurately, and in compliance with regulatory requirements such as FDA 21 CFR 820 and ISO standards.