Content for Regulators

Select content complimentary to regulators.*

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Drug Shortages

  • Risk Management for Avoidance of Drug Shortages (Article)

Facilities and Equipment

  • Using Technology for Continuous process verification 4.0 (Article)
  • Moving from cleanroom to Isolation technology for ATMPs (Article)
  • Enabling More Efficient and Effective C&Q through GEP (Article)

Information Systems

  • AI Maturity Model for GxP Application: A Foundation for AI Validation (Article)
  • The road to explainable AI in GXP-Regulated Areas (Article)


  • Agile, Data Drive Lifecycle Management for Continuous Manufacturing (Article)
  • Contamination Trends and Proposed solutions (Article)
  • Considerations for a Decentralized Manufacturing Paradigm (Article)


  • Integrating Knowledge Management and Quality Risk Management (Article)
  • Advancing Pharmaceutical Quality (APQ): Part 1 (ISPE guidance document excerpt)
  • PQLI Product Realization using Quality by Design (QbD): Concepts and Principles (ISPE guidance document excerpt)
  • PQLI Part 2 – Product Realization using Quality by Design (Q rgcmp23apq-1bD): Illustrative Example (ISPE guidance document excerpt)
  • Knowledge Management (ISPE guidance document excerpt)


  • Toward a Single Global Control Strategy: Industry Study (Article)
  • A Proposal for A Comprehensive Quality Overall Summary (Article)
  • An Evaluation of Post-approval CMC Change Timelines (Article)

Supply Chain

  • Supplier Qualification Program for Key Raw Materials (Article)
  • Streamlining Post-approval Submissions using ICH Q12 and SCDM (Article)

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