The ISPE Drug Shortage Assessment and Prevention Tool represents an important element of the implementation stage, providing a succinct way to look at the ISPE Drug Shortages Prevention Plan and analyze your risks in each of the dimensions cited and mitigate those risks. The Drug Shortage Assessment and Prevention Tool can be used as part of a company’s overall drug shortages prevention program.
First use the Drug Shortage Assessment and Prevention Tool as a reflection paper, to help you look holistically across your entire supply chain. The tool will assist you in evaluating your current processes, systems and practices and assess the risks in the 6 different dimensions compared with a ‘desired state’ as described in the ISPE Drug Shortages Prevention Plan.
The tool itself will provide a succinct way to measure your gaps from the best practices recommended in the prevention plan and assess potential risks in the supply chain and take proactive measures where possible to prevent shortages.
“This tool provides manufacturers across the spectrum of the bio/pharmaceutical industry with methods to locate current and future inconsistencies across the pharmaceutical manufacturing supply chain,” said ISPE President and CEO John Bournas. “With this tool, manufacturers will mitigate problems before they arise allowing them to provide an uninterrupted supply of safe, quality medicines to patients worldwide.”
In addition to analyzing potential gaps in your organization supply chain, use of the tool will also help you prepare for any questions a regulator may ask concerning your ability to avoid a potential drug shortage or manage an actual shortage.
The ISPE Drug Shortages Prevention Plan is an actionable plan intended to help the pharmaceutical and biopharmaceutical industry avoid drug shortages that result from manufacturing and quality issues.
Download the ISPE Drug Shortages Prevention Plan ( 3 MB)
The ISPE Drug Shortages Prevention Plan was developed by ISPE’s Drug Shortages Task Team of expert pharmaceutical and biopharmaceutical industry members.
The ISPE Drug Shortages Prevention Plan is based in part on ISPE's groundbreaking 2013 Drug Shortages Survey which investigated manufacturing quality issues as a major cause of drug shortages. The Plan is organized into six dimensions, and contains recommendations and real-world case studies in each of these dimensions:
ISPE’s Drug Shortages Prevention Plan formed part of an inter-association response to the European Medicines Agency’s (EMA’s) request to industry to provide solutions to the global problem of drug shortages caused by manufacturing. Read the report - Prevention of Drug Shortages Based on Quality and Manufacturing Issues ( 867 KB).
This research was produced at the request of FDA and examines timeframes for upgrading facilities and equipment, one of the identified causes of drug shortages. Learn more about the research - Understanding Global Regulatory Filings Timelines: Upgrading Aseptic Processing Equipment or Facilities ( 189 KB).
In February 2013, ISPE collaborated with health authorities and different sectors of the pharmaceutical industry in its initiative regarding the prevention and mitigation of drug shortages.
As a first step, ISPE's Drug Shortages Task Team developed a comprehensive electronic survey aimed at professionals working in the pharmaceutical industry.
The intent of the anonymous survey was to better understand the underlying issues and possible root causes of drug shortages. With well over 100 items in several branches of inquiry, the survey was complex and time-consuming. ISPE limited the scope of the survey to the technical and GMP compliance related issues the ISPE Task Team suspected might be contributing to drug shortages.
Know Before You Go: 2016 ISPE Biopharmaceutical Manufacturing Conference
Friday, 02 Dec 2016 17.12
Sights & Bites of San Francisco – 2016 ISPE Biopharmaceutical Manufacturing Conference
Thursday, 01 Dec 2016 13.12
ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)
Wednesday, 30 Nov 2016 18.11