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Transitioning Chemistry, Manufacturing, and Controls Content With a Structured Data Management Solution: Streamlining
Marquerita Algorri1, Nina S Cauchon2, Michael J Abernathy2
1Department of Global Regulatory Affairs and Safety-CMC, Amgen Inc., Thousand Oaks, California 91320; University of Southern California, School of Pharmacy, Los Angeles, California 90089.
Journal of Pharmaceutical Sciences
|February 1, 2020
Summary
Managing regulatory documents for global health agencies is complex and repetitive. Structured content management (SCM) offers a solution for efficient chemistry, manufacturing, and controls (CMC) data handling and regulatory submissions.
Area of Science:
- Pharmaceutical regulatory affairs
- Information management
- Regulatory science
Background:
- Regulatory document assembly for global health agencies involves repetitive authoring, editing, and data verification.
- Current manual change management for chemistry, manufacturing, and controls (CMC) data is complex and inefficient.
- Accelerated review pathways increase pressure for faster product market entry, necessitating innovative regulatory information solutions.
Purpose of the Study:
- To explore the potential of structured content management (SCM) solutions for streamlining regulatory document assembly and data verification.
- To address the challenges associated with manual CMC change management in pharmaceutical regulatory submissions.
- To investigate opportunities for automation and machine learning in interpreting regulatory data through SCM.
Main Methods:
- Review of current regulatory workflows for CMC data management.
- Analysis of structured content management (SCM) principles and their application to regulatory documents.
- Examination of FDA initiatives promoting SCM for CMC data.
Main Results:
- SCM can centralize data into manageable content blocks for cross-document use, potentially improving efficiency.
- SCM offers opportunities for automation and machine learning in the interpretation of CMC data.
- Industry and health authority collaboration is crucial for successful SCM implementation in CMC applications.
Conclusions:
- Structured content management (SCM) presents a promising approach to enhance the efficiency of regulatory document compilation, particularly for CMC data.
- Overcoming challenges in SCM implementation is key to realizing its full potential in streamlining global regulatory submissions.
- Collaborative development between industry and health authorities is essential for advancing SCM in CMC regulatory processes.
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