ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
Regulator Expectations for Data Management in Sterile Manufacturing
At the ISPE Pharma 4.0 and Annex 1 Conference, held 10-11 December 2024, Christina Meissner and Ronald Bauer, PhD, from Austrian Agency for Health and Food Safety (AGES) presented experiences with the implementation of Annex 1 in reference to Chapter 4 and Annex 11 based on new developments in the field. The presentation highlighted expectations on successful contamination control strategy implementation and on data driven manufacturing processes and quality oversight.
Approaches to Lifecycle Management and Regulatory Readiness in Advanced Therapies
A highly attended session focused on lifecycle management considerations for cell and gene therapy was held at the ISPE 2024 Annual Meeting & Expo in October. The session included perspectives from the US FDA as well as two industry experts on the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products, from initial development stages to post-market considerations.
Elevating Pharmaceutical Quality: FDA’s Office of Quality Surveillance and ISPE’s APQ™ Program
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Transformative initiatives within Office of Quality Surveillance (OQS) in FDA's Center for Drug Evaluation and Research (CDER) such as the New Inspection Protocol Project, the Drug Quality Sampling and Testing Program, and the Quality Management Maturity Program are aimed at enhancing the agency's approach to drug quality oversight. ISPE’s Advancing Pharmaceutical Quality (APQ)™ program is aimed at helping manufacturers progress continual improvement.
FDA on Pharmaceutical Compounding
While pharmaceutical compounding is sometimes referred to as the “art and science” of personalized medicine, serious adverse events associated with compounded drugs led to the development of the current statutory framework. A presentation by Ian Deveau, PhD, from the FDA Office of Compounding Quality and Compliance at the 2024 ISPE Annual Meeting & Expo provided an in-depth look at the FDA’s regulatory framework, and the events that have shaped current practices.
ISPE input to Draft Guidance, Regulations, and Consultation Documents
ISPE recently submitted comments on:
- Regulations Amending Certain Regulations Made Under the Food and Drugs Act
- ICH E6(R3) Annex 2 targeted at RWE, Risk Based approach and Remote Data Collection
- EMA consultation: Draft data strategy for the European Medicines Regulatory Network (EMRN)
- FDA Draft Guidance: Device Predetermined Change Control Plans
- See all past comments
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.