Advancing Quality in Drug Products

Quality control processes are a pivotal aspect of pharmaceutical development and manufacturing. Good manufacturing practices developed by regulators and governments around the world provide a framework for pharmaceutical companies to work within to ensure their products are safe and effective.1 Quality control (QC) and quality assurance departments are essential to drug manufacturing, and principles like quality by design (QbD) ensure companies are meeting quality requirements.2

Traditional QC activities are being expanded by artificial intelligence (AI) and other digital tools. These tools are being used by pharmaceutical companies, contract organizations, and regulators. Efforts by manufacturers to incorporate sustainable practices are also enhancing quality. And a push to move manufacturing facilities closer to home is closing the supply chain gap, making it easier to ensure quality.3

How Are Digital Tools Used in Manufacturing and Supply Chain Oversight?

AI and digital tools are shifting quality oversight in the pharmaceutical industry from retrospective testing to real-time, data-driven assurance.4,5 This change impacts the entire life cycle of drug products, from laboratory analysis to complex global supply chains.

In laboratory settings, AI is utilized to improve the reliability and speed of QC activities. AI applications enable faster root cause analysis and real-time anomaly detection.4 Natural language processing can accelerate investigations, while “virtual witnessing” tools monitor processes to detect issues early.4 For bioanalysis, the integration of AI and machine learning has the potential to significantly improve quality, efficiency, and compliance while reducing human errors.4,5

Regulators and standard-setting organizations are also incorporating AI tools. FDA launched its generative AI tool, Elsa, in the United States to accelerate clinical protocol reviews and scientific evaluations, helping reviewers ensure the safety and efficacy of regulated products.6 Digitalization is also streamlining the large amount of documentation required for regulatory compliance and market access. Generative AI is used to automate health technology assessment workflows, including screening thousands of literature abstracts and drafting clinical narratives. This ensures that the evidence used to justify a drug’s value is structured, transparent, and aligned across different global markets.7

“It appears that regulatory authorities increasingly expect submissions to be provided in structured, machine-readable formats rather than solely as static PDF documents,” says Rory Budihandojo, an independent consultant. “Consequently, this expectation compels firms to establish robust data governance practices and to strategically plan the implementation of digitalisation initiatives to ensure that data are properly structured and aligned with the required submission formats.”

The US Pharmacopeia is developing digital reference standards and digitally structured compendial methods. These tools are designed to integrate directly into digital-first workflows, providing a foundation for consistent quality as the industry adopts more automation and AI.8

Digital tools are moving quality assurance from a final checkpoint to a proactive process embedded in production, often referred to as “certification by design.”5 Real-time monitoring tools—such as process analytical technology (PAT), digital twins, and predictive models—allow manufacturers to detect and correct deviations within a validated operating space, reducing the reliance on end-product testing.5

According to Budihandojo, the FDA and other regulators encourage the use of advanced technologies to monitor quality. He states that the increased use of PAT and Internet of Things devices has resulted in more effective process monitoring and control. “For example, critical process parameters can be adjusted in real time, manufacturing data can be trended and analyzed continuously, and these capabilities may support the feasibility of real-time batch review activities,” Budihandojo explains.

Digital technologies can enhance QbD efforts, says Budihandojo, “by enabling advanced data analysis and modeling approaches, such as the Taguchi method, to aid in the creation of the design of experiments. The digital technology tools allow simulation of process parameter variations and prediction of their impact on the product quality profile. Through digital modeling and simulation, manufacturers can better understand how parameter changes affect product quality and develop effective control and monitoring strategies.”

The monitoring and auditing of suppliers is essential for pharmaceutical companies and contract manufacturers to ensure the quality of the pharmaceutical supply chain.9 Digital tools can enhance these activities. Companies like AbbVie have automated contract manufacturing organization scorecards, transforming manual processes into qualified applications that refresh nightly for better transparency.4

Tools used to conduct postmarket surveillance include AI-driven systems that classify and risk-rank patient complaints in seconds rather than minutes, enabling faster escalation of high-priority issues.4

While these various digital tools offer significant efficiency gains in several QC activities throughout a drug’s life cycle, they do not replace human judgment. Experts remain essential for validating AI outputs and providing scientific reasoning.4,7 Most regulators do not yet support AI making autonomous decisions without human supervision.4

Because data are at the centre of many of these systems, robust data governance and process harmonisation are required to ensure that the inputs used for AI models are valid and trustworthy.4,5 What is true for other processes in good manufacturing practices is true when using digital tools; work must be proven to assure regulators that quality expectations are being met. AI models must be “explainable”; if a model’s logic cannot be understood or explained, it cannot be fully trusted in a regulated environment.4

Does Moving Manufacturing Closer to Home Impact Quality?

In the United States, the White House has promoted the move of drug manufacturing from countries like India and China to the US.10One of the benefits of onshoring drug manufacturing is the potential improvement of product quality by fostering a proactive and collaborative regulatory environment that allows for more rigorous oversight compared to foreign sites.11,12 Globalized manufacturing has historically suffered from inconsistent oversight; for example, FDA foreign inspections were significantly delayed or suspended during the COVID-19 pandemic, creating a backlog that compromised timely quality assurance.13 Onshoring mitigates these geographic and political barriers, ensuring facilities remain under the continuous and pervasive oversight of domestic regulators.12

A mechanism for this improvement is FDA’s PreCheck Pilot Program, which encourages early and continuous engagement between the agency and manufacturers throughout the facility development lifecycle.11,14,15 This collaboration enables FDA to provide technical advice on facility design, quality systems, and compliance issues before operations even begin, ensuring that quality standards are integrated into the infrastructure from the outset.15

This quality shift is being supported by the Type V Drug Master File (DMF).15 This facility-centric repository captures detailed information regarding site layout and pharmaceutical quality system elements, allowing FDA to conduct more targeted pre-approval inspections.15

Onshoring often eliminates the operational friction that often undermines quality in offshore partnerships.13 In overseas facilities, time zone lags can delay the reporting and resolution of manufacturing deviations; an issue flagged in the US may not reach an expert abroad for half a day, stretching a minor fix into a multi-day exchange.13 Domestic production also resolves language and cultural nuances regarding quality reporting.13 While US teams typically expect immediate notification and root cause analysis for any issues, some foreign teams may follow more hierarchical or delayed reporting styles, which can slow the identification of critical quality risks.13

How Is Sustainability Impacting Quality?

Sustainability is impacting pharmaceutical QC by building quality through sustainability by design practices, which are similar to QbD principles, as both aim to utilize scientific data to establish a “design space” that ensures product quality while minimizing environmental impact throughout the entire life cycle.16

Sustainability efforts are assisting operational efficiency in quality testing, allowing companies to save money while reducing the consumption of natural resources.17 A key impact is the transition towards greener analytical procedures. For example, pharmaceutical companies and pharmacopoeias are updating standards to replace hazardous, toxic chemicals with environmentally friendly solvents in laboratory settings.16 Furthermore, there is a global initiative to modernize quality benchmarks by eliminating animal testing and adopting mature analytical procedures that significantly reduce material waste.17,18

The industry’s move towards Pharma 5.0 involves integrating digital systems for real-time quality improvement.17 Automated systems may limit energy use and natural resource consumption by deactivating equipment when not in use.17 Real-time analysis can prevent pollution by enhancing productivity and ensuring that sustainability gains are not lost during the scale-up from development to commercial manufacturing.16, 18

Sustainability is also driving the global harmonization of regulatory standards.16 Conflicting or redundant requirements between countries can lead to an increased environmental footprint due to inefficient testing.17 By synchronizing standards, pharmacopoeias ensure that environmental progress is consistent and measurable across the value chain.17

References

1. Quality systems approach to pharmaceutical current good manufacturing practice regulations. FDA. April 16, 2020. Accessed March 3, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations
2. Quality by design. EMA. Accessed March 3, 2026. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/quality-design
3. FDA public meeting. Onshoring manufacturing of drugs and biological products. FDA. September 20, 2025. Accessed March 3, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025
4. Lavery P. AI and digital oversight in pharma supply chains: PDA Regulatory Conference insights. PharmTech.com. September 9, 2025. Accessed March 3, 2026. https://www.pharmtech.com/view/ai-and-digital-oversight-in-pharma-supply-chains-pda-regulatory-conference-insights
5. Fagundes M. Batch certification for new manufacturing technologies: the qualified person role in a digital environment. PharmTech.com. December 1, 2025. Accessed March 3, 2026. https://www.pharmtech.com/view/batch-certification-for-new-manufacturing-technologies-the-qualified-person-role-in-a-digital-environment
6. FDA expands artificial intelligence capabilities with agentic AI deployment. FDA. News release. December 1, 2025. Accessed March 3, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment
7. Dhas A. Accelerating HTA readiness with generative AI. PharmTech.com. December 17, 2025. Accessed March 3, 2026. https://www.pharmtech.com/view/accelerating-hta-readiness-with-generative-ai
8. USP to lead development of digital quality standards to support adoption and regulatory confidence. USP. News release. January 22, 2026. Accessed March 3, 2026. https://www.usp.org/news/usp-leads-digital-quality-standards-development
9. Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations. US HHS. September 2006. Accessed March 3, 2026.https://www.fda.gov/media/71023/download
10. The White House. Regulatory relief to promote domestic production of
    critical medicines. Executive Order. May 5, 2025. https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/
11. FDA launches PreCheck Pilot Program to strengthen domestic pharmaceutical manufacturing. FDA. Press release. February 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing
12. FDA’s support for onshoring drug manufacturing and increasing oversight of foreign facilities. Jonesday.com. Insights newsletter. December 4, 2025. https://www.jonesday.com/en/insights/2025/12/fdas-support-for-onshoring-drug-manufacturing-and-increasing-oversight-of-foreign-facilities
13. Seven forces driving onshoring in biologics manufacturing. AVID Bioservices. https://avidbio.com/resource/seven-forces-driving-onshoring-in-biologics-manufacturing/ (accessed March 4, 2026).
14. FDA public meeting: onshoring manufacturing of drugs and biological products. FDA.gov. September 30, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025
15. Schwartz MI and Kim J. Onshoring drug manufacturing: insights from FDA’s PreCheck initiative and public meeting. FDA Law Blog. October 28, 2025 https://www.thefdalawblog.com/2025/10/onshoring-drug-manufacturing-insights-from-fdas-precheck-initiative-and-public-meeting/
16. Barle EL, Melton T, Judge E. Sustainability by design for pharmaceutical products. Pharmaceutical Engineering. April 2023. Accessed March 3, 2026. https://ispe.org/pharmaceutical-engineering/march-april-2023/sustainability-design-pharmaceutical-products
17. Haigney S, Lakavage A. The role of standards in sustainability. PharmTech.com. February 3, 2026. Accessed 3 March 2026. https://www.pharmtech.com/view/the-role-of-standards-in-sustainability
18. Green chemistry: a more sustainable approach to medicine development. Pfizer. November 23, 2022. Accessed March 3, 2026. https://www.pfizer.com/news/articles/green_chemistry_a_more_sustainable_approach_to_medicine_development

About the author

Susan Haigney is lead editor of PharmTech.