Select content complimentary to regulators.*
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)
Manufacturing
- Agile, Data Drive Lifecycle Management for Continuous Manufacturing (Article)
- Contamination Trends and Proposed solutions (Article)
- Considerations for a Decentralized Manufacturing Paradigm (Article)
Quality
- 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)
Regulatory
- 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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