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:
Know Before You Go: 2017 Conference on Quality Culture & Quality Metrics
Monday, 24 Apr 2017 08.04
Just Published! Pharma Records and Data Integrity GAMP Guide
Thursday, 20 Apr 2017 10.04
Meet Jazz Pharmaceuticals – 2017 FOYA Project Execution Category Winner
Wednesday, 19 Apr 2017 11.04