International Society of Pharmaceutical Engineering

About ISPE

Founded in 1980, the International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit industry trade group

Industry trade group

A trade association, also known as an industry trade group, business association or sector association, is an organization founded and funded by businesses that operate in a specific industry...

for pharmaceutical science

Science

Science is a systematic enterprise that builds and organizes knowledge in the form of testable explanations and predictions about the universe...

and manufacturing

Manufacturing

Manufacturing is the use of machines, tools and labor to produce goods for use or sale. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale...

professional

Professional

A professional is a person who is paid to undertake a specialised set of tasks and to complete them for a fee. The traditional professions were doctors, lawyers, clergymen, and commissioned military officers. Today, the term is applied to estate agents, surveyors , environmental scientists,...

s, and has 25,000 members in more than 90 countries.

ISPE's Core Purpose

ISPE aims to be the catalyst for pharmaceutical innovation by providing pharmaceutical industry professionals with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. ISPE has worldwide headquarters in Tampa, Florida

Tampa, Florida

Tampa is a city in the U.S. state of Florida. It serves as the county seat for Hillsborough County. Tampa is located on the west coast of Florida. The population of Tampa in 2010 was 335,709....

, USA; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore.

How ISPE Helps Innovate Pharmaceutical Manufacturing

ISPE offers a wide variety of resources that make solving challenges easier and enables pharmaceutical industry professionals to be more productive in their daily jobs. Along with joining a global society, professionals join a local affiliate or chapter to network and collaborate with like-minded professionals in their native language. In addition to local and global networking opportunities, ISPE offers access to industry-standard technical documents, peer-reviewed publications, industry and regulatory resources, relevant continuing education

Continuing education

Continuing education is an all-encompassing term within a broad spectrum of post-secondary learning activities and programs. The term is used mainly in the United States and Canada...

and training, and the first competency-based international certification

Certification

Certification refers to the confirmation of certain characteristics of an object, person, or organization. This confirmation is often, but not always, provided by some form of external review, education, assessment, or audit...

for pharmaceutical professionals.

The official ISPE web site (http://www.ispe.org) provides industry professionals with access to a comprehensive body of knowledge, and includes the most up-to-date information including regulatory updates, industry news, a comprehensive glossary of applied terminology, a global calendar of education and training events, Communities of Practice, discussions, technical documents, and our publications, Pharmaceutical Engineering magazine and the peer-reviewed Journal of Pharmaceutical Innovation.

Communities of Practice

Through interactive online Communities of Practice (COPs), industry professionals can access community-specific bodies of knowledge, share best practices

Best practice

A best practice is a method or technique that has consistently shown results superior to those achieved with other means, and that is used as a benchmark...

, as well as contact and engage in global networking opportunities with other like-minded colleagues. You do not have to be an ISPE member to join a COP. COPs allow participants to:

Engage in electronic discussions on topics of interest with like-minded professionals around the world
Solve everyday problems with pragmatic approaches
Collaborate on documents, important resources, and content relevant to the discipline of the community

Education and Training

ISPE’s conferences allow peers to share common problems and co-develop solutions through educational programming, networking activities, and interaction with regulatory leaders. ISPE draws from the expertise of its Members to develop courses that address current industry needs. Training instructors provide in-depth technical knowledge and skill acquisition through smaller classes designed to enhance one-on-one interaction. ISPE also offers on-site and technology-based learning opportunities for greater convenience.

Technical Documents

ISPE’s technical documents

Technical documentation

In engineering, technical documentation refers to any type of documentation that describes handling, functionality and architecture of a technical product or a product under development or use.Documentation may include:* patents...

are written by industry experts and result from global collaboration — including direct participation and review by regulatory agencies. Produced by pharmaceutical science and manufacturing industry professionals, ISPE publications provide the practical, “real world” information to help companies build on current best practices to meet and exceed regulatory standards.

Affiliates and Chapters

ISPE members can take advantage of ISPE resources on a local level through more than 40 ISPE Affiliates and Chapters that offer educational and networking opportunities. They can interact with colleagues, attend events, and make a difference right in their own neighborhoods.

Product Quality Lifecycle Implementation

ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative resulted from the need to help the pharmaceutical industry find global solutions to implementation challenges for International Conference on Harmonization (ICH) guidances. Through PQLI (www.ISPE.org/PQLI), ISPE spearheads efforts to work with industry and regulatory leaders worldwide to develop pragmatic and practical implementation of ICH guidances based on sound scientific, engineering, and business principles.

Facility of the Year Awards Program
Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, the Facility of the Year Awards program (www.facilityoftheyear.org) recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now going into its fifth year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing

Pharmaceutical manufacturing

Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies.-See also:*Chemical reactor*Chemical engineering*Pharmaceutical formulation*Medical science liaison...

technology for the benefit of all global consumers.

Certified Pharmaceutical Industry Professional^SM

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) is a global competency-based credential

Credential

A credential is an attestation of qualification, competence, or authority issued to an individual by a third party with a relevant or de facto authority or assumed competence to do so....

and the program was established as a means to answer the USFDA’s challenge to the pharmaceutical industry to innovate. Industry professionals conferred with this credential are identified as “change agents” and are assessed through demonstrated education, industry experience, and a rigorous examination. The certification offers enhanced credibility, peer respect and recognition, and greater opportunities for professional advancement.