ISPE strives to facilitate industry wide clarity of new applicable regulations, advising on impacts and resolving towards solutions, seeking harmonization of regulatory expectations where desired and possible.
ISPE engages with all levels of regulators in the development and presentation of our education, training, document development, and interpretation to ensure that our offerings are cutting-edge and focused on clarifying issues and solving problems of importance to industry.
ISPE’s Multi-Faceted Project Teams are working groups addressing broad umbrella topics in the regulatory area on the following topics:
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. Learn more about PQLI.
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.
The withdrawal of the FDA draft guidance document for the pharmaceutical industry, Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment document and lack of confidence in the results from USP <905> Uniformity of Dosage Units testing resulted in uncertainty for manufacturers, but also presented an opportunity for developing a modernized approach to enforcing the GMP requirements in this area.
Learn more about the alternative approaches the ISPE Technical Team explored to assess Blend and Content Uniformity (BUCU) including tools, publications and frequently asked questions.
The PQLI Technical Team on Breakthrough Therapies is engaging industry and regulators for open discussion on the impact of Breakthrough Therapy designation on the Chemistry, Manufacturing and Control (CMC) part of a development project.
Discussion paper: CMC Considerations When a Drug Development Project is Assigned Breakthrough Therapy Status
Authors: Earl S. Dye, PhD, John Groskoph, Brian Kelley, George Millili,PhD, Moheb Nasr, PhD, Christopher J. Potter PhD, Eric Thostesen, and Hans Vermeersch
This article discusses the impact on Chemistry, Manufacturing and Control (CMC) part of a development project when a project is assigned Breakthrough Therapy (BT) status as given in Food and Drug Administration Safety and Innovation Act (FDASIA) and FDA Guidance on Expedited Programs for Serious Conditions.
Published in Pharmaceutical Engineering magazine, Jan/Feb 2015, Volume 35, Number 1
ISPE held a successful Continuous Manufacturing Conference in April 2016, co-chaired by FDA, attended by industry professionals from 13 countries. A Special Report published in Pharmaceutical Engineering magazine, May/June 2017. This working group is developing papers for how regulatory and CGMP compliance implementation could be accomplished.
ISPE’s Process Capability Technical Team is developing guidance for industry regarding effective use of process capability measurements. Three work streams:
ISPE’s Process Validation Technical Team develops discussion papers, training courses, and continuing education conferences.
Discussion PapersView Discussion Papers
The Regulatory Quality Harmonization Committee 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 Regulatory Quality Harmonization Committee is carried out by its four Regional Focus Groups in:
For more information, contact RegulatoryAffairs@ispe.org