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Published on: November 6, 2009
Automation and digitalization in drug product process development
Sadegh Poozesh1, Mike Long2, Robert Frederick Meyer1
1Pharmaceutical Commercialization Technology, Merck & Co., Inc., Rahway, NJ, USA.
Journal of Pharmaceutical Sciences
|May 18, 2026
Summary
Pharmaceutical automation, including large language model (LLM)-based chatbots, streamlines drug product development and regulatory processes. These digital tools enhance efficiency, data integrity, and compliance within Good Documentation Practices (GDP).
Area of Science:
- Pharmaceutical Science and Technology
- Digital Transformation in Life Sciences
- Automation and Process Engineering
Background:
- The pharmaceutical industry is experiencing a digital transformation driven by the need for efficiency and cost reduction.
- Automation is a key strategy to streamline drug product (DP) process development and enhance operational efficiency.
- Existing processes often lack integration, leading to inefficiencies in data management, documentation, and regulatory interactions.
Purpose of the Study:
- To explore current trends and practical implementations of automation in pharmaceutical process development.
- To highlight the role of emerging technologies, such as large language model (LLM)-based chatbots, in pharmaceutical operations.
- To discuss the integration of automation within Good Documentation Practices (GDP) frameworks for regulatory compliance.
Main Methods:
- Review of current trends and practical implementations of automation across key pharmaceutical areas.
- In-depth analysis of mature technologies and innovative tools in automation, including LLM-based chatbots.
- Examination of real-world applications and case studies illustrating the benefits of automation.
Main Results:
- Automation is being implemented in data management, documentation, unit operations, regulatory query (RTQ) handling, and submission preparation.
- LLM-based chatbots are emerging as valuable tools for knowledge management, RTQ responses, and task automation.
- Automation offers benefits such as improved data integrity, shortened development timelines, and enhanced regulatory compliance.
Conclusions:
- Automation, particularly with LLM integration, is revolutionizing pharmaceutical process development and operations.
- Successful deployment requires adherence to Good Documentation Practices (GDP) to ensure quality, traceability, and compliance.
- The adoption of these digital solutions is critical for pharmaceutical companies to remain competitive and compliant.
Keywords:
Artificial intelligenceChemistry, manufacturing, and controls (CMC)Digital transformationDigital twinDrug product developmentLarge language modelProcess automationRegulatory complianceMore Related Videos
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