The qualification of a New Approach Methodology (NAM) through the FDA’s ISTAND Program represents a significant scientific and regulatory milestone. It signals that a NAM has demonstrated the utility and reliability necessary to be recognized as a trusted Drug Development Tool (DDT).
However, qualification alone does not guarantee long-term success. For a NAM to deliver consistent, reproducible, and credible data at scale, it must be supported by a strong Quality Management System (QMS). Without a solid quality foundation, even the most scientifically advanced NAMs risk losing reliability, client trust, and regulatory approval. Building strong quality systems prior to NAM qualification can provide additional data for your qualification submission while increasing confidence to customers and regulators alike.
The Risks of Poor Quality in NAM Operations
When quality oversight is insufficient or reactive, small inconsistencies can quickly escalate into systemic failures. These include:
- Variability between operators or testing sites
- Raw material inconsistencies and unverified supplier inputs
- Drift in protocols or equipment settings over time, or during scaling
- Equipment malfunctions or failures that compromise performance
- Data handling errors that compromise traceability
- Release of poor-quality data or materials, potentially compromising patient safety
- Erosion of customer and regulatory confidence
For qualified NAMs, these risks threaten both scientific credibility and business continuity. Without proactive quality management, scaling operations can expose vulnerabilities that are difficult to correct once in production or under regulatory review.
Building ISO 9001 Quality Systems for NAM Developers
A traditional pharmaceutical QMS often does not align perfectly with the unique challenges of NAM development. However, ISO 9001 offers a flexible and internationally recognized framework that can be adapted to NAMs across diverse types of technology: from AI-driven analytics to organ-on-a-chip systems.
A well-structured, NAM-specific QMS should incorporate:
- Leadership Commitment to Quality: Executive and scientific leaders must drive a culture of quality, ensuring that accountability and continuous improvement are embedded throughout the organization. This commitment must be reinforced through regular internal audits and formal management review. Customer focus should extend to both paying clients and relevant regulatory agencies.
- Change Control: Every modification to protocols, materials, or software should undergo review and risk assessment before implementation. Major changes must be controlled to ensure the integrity of the Context of Use. Newly integrated components within the NAM should follow rigorous Design Control practices.
- Documentation Control: Standardized, version-controlled procedures should be used in all processes to maintain consistency and support audit readiness. Records should be maintained to GDP standards and/or 21 CFR Part 11 requirements. Changes or updates to SOPs must be tracked, reviewed, approved, and deployed.
- Personnel and Training: Defined competency requirements and documented training are maintained to ensure consistency and reproducibility in all experimental and analytical work.
- Facility and Equipment Maintenance: Lab space and relevant equipment must be maintained to the highest standards. Regular preventive maintenance and calibration activities must be completed and documented. Access to laboratory spaces, archives, and restricted servers must be controlled and limited to authorized personnel.
- Vendor and/or Raw Material Evaluation: Supplier qualification should be conducted to ensure reliability of critical reagents, materials, and/or data inputs. Vendor performance must be tracked over time to ensure consistency of inputs. Specialized, internally produced materials and resources must be evaluated and released as though obtained through an external supplier.
- Release Requirements: Robust quality control metrics must be established with review by the Quality Assurance Unit. Stringent pass/fail metrics must be enforced to ensure only accurate and compliant data are released to clients or regulators. For complex operations or unique scientific applications, well-validated internal standards must be maintained.
- Continuous Improvement: Performance monitoring and process analysis should identify and correct trends that could affect data quality. A culture of continuous improvement should be fostered.
Other Quality Standards
To date, there has been no public statement by regulators requiring NAM developers to be GLP compliant to achieve qualification. However, the FDA has made it clear that GLP (or other GxP) requirements may be introduced as a prerequisite to qualification (contact us for citation). Building a quality framework early is critical to ensure developers can meet GLP compliance, as required. Additionally, for specific NAMs applications, alternative ISO standards (such as 13485, 17025, 27001, or 42001) may be appropriate.
Quality and Qualification: Sustaining Confidence Beyond ISTAND
Achieving qualification through the FDA ISTAND Program marks an important accomplishment for a NAM. Maintaining that recognition requires scientific discipline and ongoing quality oversight.
A QMS rooted in ISO 9001 principles ensures that once a NAM is qualified, it continues to meet its intended Context of Use. It supports audit readiness, enhances operational efficiency, and provides a framework for continuous improvement and risk mitigation.
At InnovApproach Consulting, we specialize in helping NAM developers design and implement quality systems that grow with their innovation. We have hands-on experience designing Quality Management Systems that are purpose-built for NAMs undergoing active qualification.
Partner with InnovApproach Consulting to build a scalable, ISO 9001-aligned quality system that strengthens your data, your credibility, and your qualification.
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