Global Inspection Trends: New Developments in Quality Management

In 2025, significant changes are occurring in the way inspections are conducted. The traditional “formal audit” approach is gradually evolving into a more transparent and effective global quality assurance system. This transformation represents a critical initiative that influences both international competitiveness and product quality for companies worldwide.

The Evolution of Inspections: The Expansion of Unannounced Inspections

Traditional Inspection Models

Historically, inspections have often been conducted with advance notice in prepared environments. Companies, knowing the inspection date in advance, could ensure everything was in perfect order. However, this approach made it difficult to accurately assess the true state of quality management practices.

New Developments in Unannounced Inspections

The FDA has been progressively expanding unannounced inspections at foreign manufacturing facilities, with increased emphasis on this approach in recent years. This new methodology aims to evaluate companies’ ongoing quality management systems as they function in routine operations.

Unannounced inspections are characterized by the following features:

• Surprise implementation enables assessment of day-to-day quality management levels
• Elimination of superficial responses that might result from advance notification
• Accurate understanding of actual quality management practices at foreign facilities

This approach represents a fundamental shift in regulatory philosophy, from evaluating what companies can demonstrate when prepared to assessing how they actually operate under normal conditions.

Strengthened Inspections of Overseas Facilities: Progress in Global Quality Management

Challenges in International Quality Management

In the global economy, quality management failures at a single facility can have severe repercussions throughout the entire supply chain. Regulatory authorities worldwide recognize this interconnected risk and have intensified their oversight of international manufacturing operations.

The FDA, for example, conducts thousands of foreign inspections annually across more than 90 countries, making it one of the most active regulatory bodies in global pharmaceutical and medical device oversight. These inspections cover a wide range of facilities, from active pharmaceutical ingredient (API) manufacturers to finished drug product facilities and medical device manufacturing sites.

Current State of Overseas Facility Inspections

As of 2025, inspections of overseas facilities are beginning to exhibit the following characteristics:

Utilization of Remote Inspection Technology

The COVID-19 pandemic served as a catalyst for the adoption and refinement of remote audits and inspections. What began as an emergency measure has evolved into a sophisticated inspection methodology that complements traditional on-site inspections.

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has established comprehensive electronic document systems and virtual site tour capabilities, enabling regulators to:

• Conduct real-time document reviews through secure digital platforms
• Perform virtual walkthroughs of manufacturing facilities using high-definition video technology
• Observe manufacturing processes remotely while maintaining the integrity of the inspection
• Reduce travel time and costs while maintaining inspection frequency

However, it is important to note that remote inspections typically complement rather than replace on-site inspections, particularly for high-risk facilities or when significant concerns are identified.

International Quality Management Cooperation

Global regulatory harmonization efforts have significantly advanced through several key initiatives:

Medical Device Single Audit Program (MDSAP): This program, specifically designed for medical device manufacturers, allows a single audit to satisfy the requirements of multiple participating regulatory authorities. Currently, regulatory bodies from Australia, Brazil, Canada, Japan, and the United States participate in MDSAP. This program reduces the burden of multiple inspections while maintaining rigorous quality standards across jurisdictions.

Pharmaceutical Inspection Co-operation Scheme (PIC/S): This international organization works toward harmonizing Good Manufacturing Practice (GMP) inspection procedures worldwide. As of early 2025, PIC/S comprises over 50 participating authorities from more than 50 countries and regions. PIC/S membership signifies that a regulatory authority adheres to internationally recognized GMP standards and inspection procedures, facilitating mutual recognition of inspection outcomes.

These collaborative frameworks represent significant progress toward creating a unified global quality assurance system, reducing duplicative inspections while enhancing overall quality standards.

Practical Response Strategies

New Approaches Required of Companies

1. Establishing Continuous Quality Management Systems

Companies must fundamentally shift their quality mindset from “inspection readiness” to “continuous compliance.” This transformation requires:

Daily quality management assuming unannounced inspections: Organizations must maintain their facilities, documentation, and processes at inspection-ready status at all times. This means that quality standards become embedded in daily operations rather than being special preparations for scheduled audits.

Implementation of real-time quality monitoring systems: Modern quality management increasingly relies on continuous monitoring technologies that can:

• Track critical quality parameters in real-time
• Generate automated alerts when deviations occur
• Provide immediate visibility into quality trends
• Enable rapid corrective action before issues escalate

Many leading pharmaceutical and medical device manufacturers have implemented sophisticated Manufacturing Execution Systems (MES) and Quality Management Systems (QMS) that integrate these capabilities, transforming quality management from a reactive to a proactive discipline.

2. Responding to Global Standards

Rapid adaptation to international quality standards: As regulatory requirements continue to evolve and harmonize globally, companies must establish mechanisms to:

• Monitor changes in international regulations and standards (such as ICH guidelines, ISO standards, and regional GMP requirements)
• Assess the impact of regulatory changes on their operations
• Implement necessary modifications in a timely manner
• Maintain compliance across multiple jurisdictions simultaneously

Development of cross-cultural quality management teams: Global operations require teams that can:

• Navigate diverse regulatory environments across different countries
• Communicate effectively across cultural and linguistic boundaries
• Understand regional variations in regulatory interpretation and enforcement
• Transfer best practices across international operations while respecting local requirements

This often involves establishing regional quality leadership positions, creating cross-functional global quality teams, and investing in training programs that build both technical and cultural competencies.

3. Transparent Corporate Culture

Open quality improvement approach: Leading organizations are embracing transparency as a core principle of their quality culture. This includes:

• Proactively identifying and reporting quality issues rather than concealing them
• Sharing quality metrics and performance data across the organization
• Encouraging open dialogue about quality challenges and improvement opportunities
• Establishing blame-free reporting systems that focus on system improvement rather than individual fault-finding

Organizational culture that views inspections as learning and growth opportunities: Rather than viewing regulatory inspections as adversarial events to be endured, forward-thinking companies treat them as valuable sources of external insight. This perspective shift involves:

• Welcoming inspector observations as opportunities to identify blind spots
• Conducting thorough post-inspection reviews to extract maximum learning
• Implementing inspector recommendations even when not strictly required
• Sharing inspection learnings across the organization to drive continuous improvement

Organizations that successfully adopt this mindset often find that their quality systems become more robust and their regulatory relationships more collaborative over time.

Future Outlook

Notable International Initiatives

Gradual Introduction of AI Technology

Artificial intelligence and machine learning are beginning to transform quality management in manufacturing settings. Real-world implementations demonstrate significant potential:

Practical applications in anomaly detection systems: AI-powered systems are being deployed to:

• Identify subtle patterns in manufacturing data that might indicate emerging quality issues
• Predict equipment failures before they occur through predictive maintenance algorithms
• Detect counterfeit or substandard materials through advanced analytical techniques
• Optimize manufacturing parameters to reduce variation and improve consistency

Achievements in AI quality management at major manufacturers: Industry leaders such as Toyota and Bridgestone have reported significant successes with AI-driven quality systems, including:

• Reduced defect rates through early detection of process deviations
• Improved efficiency by automating routine quality checks
• Enhanced traceability through AI-powered data integration
• Better decision-making through real-time analytics and visualization

However, it is important to note that regulatory validation of AI systems remains an evolving area. Companies implementing AI in quality-critical applications must ensure these systems are properly validated, maintain appropriate human oversight, and comply with relevant regulatory guidance such as the FDA’s discussion papers on AI/ML in medical devices and the EU’s emerging AI regulations.

Harmonization of International Quality Management

Expansion of mutual recognition systems: Regulatory authorities are increasingly recognizing each other’s inspection outcomes, reducing duplicative inspections while maintaining quality standards. Examples include:

• The EU-US Mutual Recognition Agreement (MRA) for pharmaceutical GMP inspections, which allows regulatory authorities to rely on each other’s inspection reports
• Similar arrangements being developed in other regions and for other product categories
• Efforts to expand these agreements to include more countries and broader product scopes

Progress in bilateral agreements such as the AEO mutual recognition between Singapore and India: Authorized Economic Operator (AEO) programs, while primarily focused on customs and trade security, exemplify how international cooperation can streamline compliance while maintaining rigorous standards. The mutual recognition arrangement between Singapore and India demonstrates:

• How trust-based frameworks can reduce redundant verifications
• The benefits of aligning standards and procedures across borders
• The potential for similar approaches in pharmaceutical and medical device quality management

Initiative	Scope	Participating Regions/Countries	Key Benefits
PIC/S	GMP Inspection Harmonization	50+ countries/regions	Standardized inspection procedures, mutual reliance
MDSAP	Medical Device Single Audit	Australia, Brazil, Canada, Japan, USA	Single audit satisfies multiple regulators
EU-US MRA	Pharmaceutical GMP	European Union, United States	Reduced duplicate inspections
AEO Programs	Trade Security/Quality	Multiple bilateral agreements globally	Streamlined customs, reduced inspections

These harmonization efforts represent significant progress toward a truly integrated global quality system, though challenges remain in areas such as differing regulatory philosophies, resource constraints, and the need to maintain sovereignty over public health decisions.

Conclusion

Inspections are evolving from mere formalistic checks into more strategic and effective processes. It is crucial to embrace this change positively and pursue continuous quality improvement and adaptation to international standards.

The most important aspect is leveraging the insights generated through inspections to create higher-quality and more reliable products and services. In this era of globalizing quality management, several key principles will determine organizational success:

Continuous readiness rather than periodic preparation: Organizations must embed quality into their daily operations so thoroughly that inspection readiness becomes the natural state of the business rather than a special condition requiring preparation.

Embracing transparency as a competitive advantage: Companies that openly address quality challenges and share their learnings often build stronger reputations and more collaborative relationships with regulators, ultimately gaining competitive advantages in the marketplace.

Viewing global standards as opportunities, not burdens: While international harmonization creates complexity, it also opens doors to global markets and creates efficiencies through standardization. Organizations that lead in adopting global standards often find themselves better positioned for international expansion.

Investing in people and culture: Technology and systems are important, but sustainable quality management ultimately depends on creating organizational cultures where quality is valued, quality issues are addressed openly, and continuous improvement is pursued systematically.

Balancing innovation with compliance: As technologies like AI, advanced analytics, and automation transform manufacturing, companies must find ways to innovate within regulatory frameworks, working collaboratively with regulators to ensure new approaches meet quality and safety requirements.

In the globalizing era of quality management, flexible responsiveness and continuous learning will be the keys to corporate success. Organizations that view these changes not as burdens but as opportunities to strengthen their competitive position will be best equipped to thrive in an increasingly interconnected and regulated global marketplace.

The future of quality management lies not in perfect compliance with static standards, but in building adaptive systems that can evolve with changing requirements while never compromising on the fundamental commitment to product quality and patient safety. This dynamic approach to quality—one that embraces change, learns from experience, and continuously improves—represents the next frontier in pharmaceutical and medical device manufacturing excellence.