ISPE’s Drug Shortage Initiative is facilitating communication between the pharmaceutical industry and global health authorities to understand and address this complex problem.
ISPE is conducting the industry’s first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the FDA. The pilot will refine the proposed set of metrics and definitions, data submission process, and evaluation.
An ISPE-sponsored group of regulators, industry, and academia are identifying alternative approaches to assess Blend and Content Uniformity.
The RCC’s role is to build effective partnerships with regulators and agencies globally and ensure all ISPE Members have access to the latest regulatory developments and expectations.
RCC Regional Focus Groups facilitate global activity:
Through PQLI, ISPE assists industry and regulators in advancing manufacturing sciences across the product lifecycle in order to achieve excellence in drug development and in pharmaceutical production. Manufacturing sciences shall be defined as the integrated application of scientific knowledge, technical innovation and quality risk management to deliver product and process understanding.
PQLI Technical Committees address various key topics:
Data Integrity: Do You GAMP?
Friday, 24 Mar 2017 13.03
Nominate Your Facility for 2018 Facility of the Year Awards
Thursday, 23 Mar 2017 18.03
New Format Highlights 2017 ISPE/FDA/PQRI Quality Manufacturing Conference
Wednesday, 22 Mar 2017 16.03