ISPE Celebrates 25 Years of “Engineering Pharmaceutical Innovation”
(TAMPA, FL, USA, March 30, 2005) - ISPE, the International Society for Pharmaceutical Engineering, marks its 25th anniversary this year with a full schedule of activities commemorating the Society’s contributions to innovation in pharmaceutical manufacturing. ISPE was founded in 1980 to discuss the formation of an engineering society whose primary purpose would be focused on education, networking, and the exchange of information for pharmaceutical manufacturing professionals. Twenty-five years later, the Society continues to fill a void in this important area of the pharmaceutical industry, honoring Member contributions and their commitment to professional excellence based on scientific and technical merit.
“ISPE’s vision for the future is to lead the integration of industry professionals, academia, and regulatory agencies worldwide to achieve real innovation in pharmaceutical product delivery,” said Paul D’Eramo, chairman of ISPE. “The Society is committed to developing innovative professionals to achieve technical and operational excellence in the pharmaceutical industry.”
A Heritage of Industry Collaboration
Working with industry and regulatory agencies has been the goal of the Society since its early days, when a core group of individuals set out to provide a baseline for the industry and regulatory agencies in designing, building, and validating pharmaceutical facilities. ISPE continues to take on such initiatives, providing the training, collaboration, and communications they require.
As a result of the continued efforts from volunteer leaders, the U.S. Food and Drug Administration (FDA) has recently invited ISPE to play a leading role in driving innovation in pharmaceutical manufacturing and called for the Society to be the “Catalyst of Change,” proposing the adoption by industry of a technology that will lead to better efficiency, safer products, and production cost savings in the long run. The jointly sponsored FDA/ISPE Process Analytical Technology (PAT) Forums, which were held in the U.S.; Brussels, Belgium; Tokyo, Japan; and Mumbai, India; underscore the important role ISPE plays in this area.
In the realm of technical documents, the Society is currently working on more than 15 publications, 10 of which are slated for completion in 2005 on topics such as electronic records and signatures; packaging, labelling, and warehousing operations; and PAT. Subject to intensive peer review, these publications are the work product of teams of recognized experts who take the collective knowledge of leading thinkers on manufacturing best practices and regulatory compliance, and make it available in an easy-to-use format. Several are developed through a joint collaboration with the U.S. Food and Drug Administration (FDA) and other global regulatory bodies.
Looking Ahead
Other significant projects such as professional certification, the introduction of a science-based peer-reviewed technical journal, stronger university relations, and the Engineer of the Future initiative are currently being developed by ISPE. With a strong team of Regulatory Affairs Advisors from the U.S., Europe, and the Asia-Pacific region, who have established contact with more than 25 regulatory agencies around the world, many of these activities will have the global perspective that has become a standard for innovation at ISPE.
The fast-paced growth of the Society during the past 25 years has called for the development of Communities of Practice (CoP) in diverse areas such as process/product development, biotechnology, active pharmaceutical ingredients, commissioning and qualification, sterile products processing, and PAT. ISPE Communities of Practice are being formed by groups of like-minded professionals to address similar industry trends and related issues through opportunities for networking and personal interaction.
About ISPE
ISPE is the Society of choice for nearly 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida and a European office in Brussels, Belgium. Visit www.ispe.org for additional Society news and information. ■
ISPE Celebrates 25 Years
ISPE Celebrates 25 Years of “Engineering Pharmaceutical Innovation”
(TAMPA, FL, USA, March 30, 2005) - ISPE, the International Society for Pharmaceutical Engineering, marks its 25th anniversary this year with a full schedule of activities commemorating the Society’s contributions to innovation in pharmaceutical manufacturing. ISPE was founded in 1980 to discuss the formation of an engineering society whose primary purpose would be focused on education, networking, and the exchange of information for pharmaceutical manufacturing professionals. Twenty-five years later, the Society continues to fill a void in this important area of the pharmaceutical industry, honoring Member contributions and their commitment to professional excellence based on scientific and technical merit.
“ISPE’s vision for the future is to lead the integration of industry professionals, academia, and regulatory agencies worldwide to achieve real innovation in pharmaceutical product delivery,” said Paul D’Eramo, chairman of ISPE. “The Society is committed to developing innovative professionals to achieve technical and operational excellence in the pharmaceutical industry.”
A Heritage of Industry Collaboration
Working with industry and regulatory agencies has been the goal of the Society since its early days, when a core group of individuals set out to provide a baseline for the industry and regulatory agencies in designing, building, and validating pharmaceutical facilities. ISPE continues to take on such initiatives, providing the training, collaboration, and communications they require.
As a result of the continued efforts from volunteer leaders, the U.S. Food and Drug Administration (FDA) has recently invited ISPE to play a leading role in driving innovation in pharmaceutical manufacturing and called for the Society to be the “Catalyst of Change,” proposing the adoption by industry of a technology that will lead to better efficiency, safer products, and production cost savings in the long run. The jointly sponsored FDA/ISPE Process Analytical Technology (PAT) Forums, which were held in the U.S.; Brussels, Belgium; Tokyo, Japan; and Mumbai, India; underscore the important role ISPE plays in this area.
In the realm of technical documents, the Society is currently working on more than 15 publications, 10 of which are slated for completion in 2005 on topics such as electronic records and signatures; packaging, labelling, and warehousing operations; and PAT. Subject to intensive peer review, these publications are the work product of teams of recognized experts who take the collective knowledge of leading thinkers on manufacturing best practices and regulatory compliance, and make it available in an easy-to-use format. Several are developed through a joint collaboration with the U.S. Food and Drug Administration (FDA) and other global regulatory bodies.
Looking Ahead
Other significant projects such as professional certification, the introduction of a science-based peer-reviewed technical journal, stronger university relations, and the Engineer of the Future initiative are currently being developed by ISPE. With a strong team of Regulatory Affairs Advisors from the U.S., Europe, and the Asia-Pacific region, who have established contact with more than 25 regulatory agencies around the world, many of these activities will have the global perspective that has become a standard for innovation at ISPE.
The fast-paced growth of the Society during the past 25 years has called for the development of Communities of Practice (CoP) in diverse areas such as process/product development, biotechnology, active pharmaceutical ingredients, commissioning and qualification, sterile products processing, and PAT. ISPE Communities of Practice are being formed by groups of like-minded professionals to address similar industry trends and related issues through opportunities for networking and personal interaction.
About ISPE
ISPE is the Society of choice for nearly 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida and a European office in Brussels, Belgium. Visit www.ispe.org for additional Society news and information. ■