Regulatory Initiatives, Current Topics, and Groups

Multi-Faceted Project Teams

ISPE’s Multi-Faceted Project Teams are working groups addressing broad umbrella topics in the regulatory area. 

Product Quality Lifecycle Implementation® (PQLI)

PQLI is ISPE’s initiative for a practical approach to implementation of International Conference on Harmonization (ICH) guidances Q8 (R2), Pharmaceutical Development; Q9, Quality Risk Management; Q10, Pharmaceutical Quality System; and Q11, Development and Manufacture of Drug Substances. 

PQLI Technical Teams

PQLI Technical Teams are working groups addressing broad cutting edge regulatory and compliance issues that affect industry across dosage forms and in small and large molecules. 

  • Blend Uniformity/Content Uniformity
  • Breakthrough Therapies
  • Continuous Manufacturing
  • Knowledge Management
  • Process Capability
  • Process Validation

Regulatory Quality Harmonization Committee (RQHC)

The RQHC builds effective partnerships with regulators and agencies globally and ensures ISPE Members have access to the latest regulatory developments and expectations. The work of the RQHC is carried out by its four Regional Focus Groups in Asia-Pacific, Europe-Middle East-Africa (EMEA), Latin America, and North America.
More about RQHC

For more information, contact