ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
ISPE Issues Report on Barriers to Innovation
Industry reports experiencing regulatory divergence in the interpretation and implementation of ICH guidelines - and control strategies - across geographic regions. This report includes insights from a survey of nearly 400 industry respondents on the extent and severity of challenges/barriers globally in developing and implementing innovative technologies. VIEW REPORT
International Regulatory Dialog at 2024 ISPE Europe Annual Conference
In April more than 700 industry professionals gathered in Lisbon, Portugal to discuss regulatory and quality challenges and solutions, and harmonization initiatives. Participants included more than 20 international regulators from Australia, Denmark, Italy, Netherlands, Portugal, Saudi Arabia, Switzerland, the United Kingdom, and the US. Read summaries of select presentations and panel discussions:
USFDA: Views on QRM in Design, Control, and Maintenance
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in the US FDA’s Center for Drug Evaluation and Research (CDER), offered a keynote address titled “Modernizing Facilities: Use of QRM in Design, Control, and Maintenance.
Regulatory Panel: Harmonization for Robust Supply Chains
On 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal, a panel discussion titled “Harmonization to Break Down Barriers to Robust Supply Chains” featured an international panel of experts who discussed drug recalls, drug shortages, risks that can lead to poor drug product quality, quality risk management, Annex 1 implementation and its effect on the supply chain, inspector training and knowledge in an era of scientific and technical change, and efforts needed for building a more resilient supply chain.
EMA: European Initiatives to Advance Manufacturing Digitalization
One of the keynote sessions of the 2024 ISPE Europe Annual Conference held 16-18 April in Lisbon, Portugal was a presentation on EU initiatives to advance digitalization in manufacturing by Evdokia Korakianiti, Head of Quality and Safety for the Human Medicines Division of the European Medicines Agency (EMA).
USFDA: De-Risking Aseptic Processing Operations: Insights from the 2024 ISPE Europe Annual Conference
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality, on 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal. The presentation, titled Using Quality Risk Management to De-Risk Your Aseptic Processing Operation, highlighted how risk management practices can enhance the reliability and safety of aseptic processing and protect patients from exposure to non-sterility risks.
Annex 1 Implementation a key topic of 2024 ISPE Aseptic Conference
How the updated Annex 1 is impacting the manufacturing of sterile products was of prime interest to attendees and regulators alike at the at the 2024 ISPE Aseptic Conference in Vienna, Austria. Keynotes by regulators from the Austrian Agency for Health and Food Safety and Tuebingen, Germany focused on implementation strategies and solutions that are reshaping the industry and enhancing contamination control.
Regulatory Concerns in Asia-Pacific
ISPE’s Regulatory Quality Harmonization Committee (RQHC)’s Asia-Pacific Regional Focus Group tracks and disseminates regulatory, quality and compliance developments in the region. The RQHC Asia-Pacific group includes pharmaceutical professionals located in or having specific responsibility for Asian markets. Read some of the topics recently surfaced by the group:
Common Technical Document (CTD) Challenges in Emerging Markets
Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies. As markets become more familiar with the CTD, especially the quality portion, some drug regulatory agencies are requesting more regional/local documents and customization to CTD documents in accordance with their local interpretation and understanding of the ICH M4Q(R1) guideline, “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.” It may be that the agency wants to find specific information quickly and easily, such as the manufacturer of the master and/or working cell bank.
Balancing Drug Product Traceability and Supply Flexibility in the Philippines
During the COVID-19 pandemic, vaccines were one of the drug products recommended by the World Health Organization (WHO) to fight the pandemic. The majority of regulators have flexed their local regulatory requirements to bring vaccines to the market with as much supply flexibility as possible, including emerging markets which typically have challenging local requirements that a marketing authorization holder (MAH) must meet. For example, many markets have been willing to accept Europe and US content without further customization. In addition, regulators have granted approval of post-approval variations with brief review periods to allow companies to have supply continuity.
ISPE Regulatory Resources
This quarterly newsletter is dedicated to news about ISPE’s regulatory and quality activities.
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.