Regulatory Matters

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ISPE Represented at PIC/S 50th Anniversary Event

23 November 2022

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin, Ireland on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium was titled “Thriving at 50 and Striving Forward” and was aimed at promoting and...

News & Press Releases

ISPE Invited to Participate in DAF ACT Initiative to Support Domestic Manufacturing of Active Pharmaceutical Ingredients

17 December 2020

ISPE announced their participation in the Department of the Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise Regulatory, Technical, and Workforce elements favorable to creating a more robust and sustainable domestic pharmaceutical...

News & Press Releases

New Cultural Excellence Report

05 May 2017

ISPE released a new Cultural Excellence Report announced at its Conference on Quality Culture and Quality Metrics in Bethesda, Maryland, 25 April 2017. Cultural excellence recognizes quality not as an operational burden or compliance requirement, but...

News & Press Releases

The Pew Charitable Trusts & ISPE Drug Shortages Study

09 January 2017

Working with The Pew Charitable Trusts (Pew), the International Society for Pharmaceutical Engineering (ISPE) today released the results of a joint study, Drug Shortages: An Exploration of the Relationship between U.S. Market Forces and Sterile...

News & Press Releases

Release of ISPE Quality Metrics Wave 2 Report Enables a Continued Data-Driven Dialogue with the FDA

06 June 2016

(Bethesda, Maryland, USA, 6 June 2016) – The International Society for Pharmaceutical Engineering (ISPE) will release the results of its Quality Metrics Pilot Program, Wave 2, at the ISPE/FDA/PQRI Quality Manufacturing Conference, 6–8 June 2016 in...

News & Press Releases

ISPE Developing Gap Analysis Tool to Help Ensure an Uninterrupted Supply of Medicines

04 May 2015

International Society for Pharmaceutical Engineering (ISPE) to announce at its Annual European Conference in Frankfurt, Germany, the development of a tool to aid manufacturers in locating gaps in production and quality systems – an important element...

News & Press Releases

ISPE Plan to Prevent Drug Shortages Released

15 October 2014

Experts team-up to help keep quality medicines available to those who need them (Tampa, Florida, USA, 15 October 2014) - ISPE, the International Society for Pharmaceutical Engineering, released its Drug Shortages Prevention Plan at its 2014 Annual...

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Drug Shortages Prevention Plan Released

15 October 2014

ISPE released its Drug Shortages Prevention Plan yesterday during 2014 Annual Meeting in Las Vegas, Nevada. Regulators from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Medicines and Healthcare Products...

News & Press Releases

ISPE Releases First Look at its Plan to Prevent Drug Shortages

27 August 2014

(Tampa, Florida, USA, 27 August, 2014) - ISPE, the International Society for Pharmaceutical Engineering, announced today that it has released a preview of its Drug Shortages Prevention Plan aimed at helping the pharmaceutical industry avoid drug...

News & Press Releases

ISPE Quality Metrics Pilot Program Proceeding as Planned

23 April 2014

ISPE will conduct the industry’s first Quality Metrics Pilot Program . The year-long program will test a series of leading and lagging indicators that could support an FDA risk-based inspection program in lieu of biennial inspections, as directed by...