ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
FDA on AI in Pharmaceutical Manufacturing
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At ISPE’s 2024 Biotechnology Conference, Sharmista Chatterjee, PhD, director of the US Food and Drug Administration’s Division of Pharmaceutical Manufacturing Assessment III, discussed the Agency’s AI strategy and areas where FDA sees potential for industry implementation.
A Holistic Approach to Supply Resiliency
Supply resiliency for pharmaceutical manufacturing has been a topic of increasing interest to global stakeholders, resulting in wide-spread attention and many perspectives on how to improve drug shortages and associated vulnerabilities in the drug supply chain. ISPE’s Drug Shortages team addresses this multi-layer challenge with recommendations for cross-functional alignment, robust business partnerships, and constructive health authority interactions to ensure the best possible outcomes.
ISPE Regulatory Perspectives in Pharmaceutical Engineering® Magazine
The latest issue of Pharmaceutical Engineering® magazine features insights from several of ISPE’s regulatory committees and working groups.
- Drug Shortages Global Convergence Opportunities
- Industry Perspectives on Practical Application of Platform Analytical Procedures
- Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
- PIC/S in Latin America: Harmonization of cGMP Procedures
- FDA’s 2011 Process Validation Guidance: 10 Years On
Quality Management Maturity Industry Study
ISPE is partnering with the University of St.Gallen to conduct an industry study on ICH Q10 PQS maturity and quality practices including culture. The study is based on the ISPE Advancing Pharmaceutical Quality™ Program with St.Gallen pre- and post-assessments. Participants will receive individualized analytical reporting benchmarked against industry. Contact matteo.bernasconi@unisg.ch for further information or to enroll.
ISPE input to Draft Guidance, Regulations, and Consultation Documents
ISPE recently submitted comments on:
- EMA Preliminary QIG Considerations regarding Pharmaceutical Process Models
- EMA Proposed amendments to the European Commission guidelines on variations categories and procedures
- FDA Draft Guidance: Platform Technology Designation Program for Drug Development
- FDA Draft Guidance: Potency Assurance for Cellular and Gene Therapy Products
- FDA Draft Guidance: Purpose and Content of Use Related Risk Analyses for Drugs, Biological Products, and Combination Products
- IMDRF: Good machine learning practice for medical device development - Guiding Principles