QUALITY & COMPLIANCE
NGT recognizes the critical importance of quality and compliance, especially in the highly regulated biopharmaceutical industry. Our expert consultants work collaboratively with our clients to ensure GxP compliance, from preclinical through clinical development and beyond to commercialization and life-cycle management. NGT services include the following:
- GxP audits and inspection readiness (e.g., due diligence, internal, supplier/vendor, CDMO/CMO/CRO)
- Regulatory action response (e.g., FDA 483’s, Warning Letters, Consent Decree, and equivalent)
- Quality Management System development
- Quality Risk Management strategy
- Management controls and performance metrics
- Data integrity
- Manufacturing and laboratory investigations
- Change control management
- Corrective Action/Preventive Action (CAPA) strategy and effectiveness
- Batch release
- Product complaint and recall management
- Validation/qualification of facilities, utilities, equipment, analytical methods, processes, and computer systems
- Supplier and vendor qualification and management
- GxP documentation development/review (e.g., procedures, protocols, reports, analytical methods, specifications, batch records, training materials, master plans)
CASE STUDY – Quality Management System Design & Implementation
Situation
A start-up pharmaceutical company with a promising pre-clinical development drug candidate wanted to utilize an existing non-GMP facility to manufacture clinical, and potentially commercial, supplies of the compound.
Solution
An extensive evaluation of the company’s existing facility, processes and procedures was conducted. To ensure compliance with current Good Manufacturing Practices (cGMP), a fully cGMP compliant Quality Management System (QMS) was designed and implemented for the existing facility.
Impact
Implementation of the QMS system ensured that the existing facility was cGMP compliant for both clinical and commercial drug manufacturing. With a cGMP compliant facility, the client could proceed to manufacture their promising drug candidate for clinical development. Overall, converting the existing facility to a cGMP compliant facility resulted in substantial cost savings and an accelerated clinical development timeline.
