November / December 2020
Memorable Milestones: 40 Years of ISPE
ISPE is celebrating its 40th anniversary this year! Here are some of the memorable events from the last 40 years.
- In August six men met to discuss the formation of an engineering society that would primarily focus on education, networking, and the exchange of in-formation. They chose the name “International Society of Pharmaceutical Engineers.” A three-person staff was retained.
- Pharmaceutical Engineering® published its first issue in November 1980-January 1981, initially publishing on a quarterly basis.
- ISPE’s relationship with the US FDA began. In February, the FDA spoke in Tampa, Florida, at the first ISPE seminar, “Upgrading to Meet cGMPs.”
- In the first year, ISPE membership reached 430.
- The first Annual Membership Meeting and Awards Banquet was held in November in Philadelphia, in conjunction with PACK INFO ’81.
- Pharmaceutical Engineering began to publish bimonthly with the July-August issue.
- Bob Best became ISPE’s Executive Director.
- The first North American Chapter was formed in New Jersey.
- A member newsletter was launched.
- ISPE sponsored its first International Pharmaceutical Engineering Forum during the Annual Meeting held in November in St. Petersburg Beach, Florida.
- ISPE membership grew to 1,000.
- ISPE’s first European venture, the International Congress of Pharmaceutical Engineering, took place in September in Brussels.
- The first two Affiliates were formed in 1989–1990 in the UK and Ireland.
- The Society’s name was changed slightly from “International Society of Pharmaceutical Engineers” to “International Society for Pharmaceutical Engineering.”
- ISPE staff grew to nine employees.
- The ISPE Editorial Committee unanimously chose ISPEAK as the official name of the ISPE newsletter in March.
- The New Jersey Institute of Technology became ISPE’s first official Student Chapter.
- ISPE opened a European office in The Hague, Netherlands, with six employees.
- Volunteer leaders from North America and Europe wrote ISPE’s first strategic plan and mission statement.
- ISPE implemented strategic objectives by establishing North American and European Operating Committees.
- The D/A/CH Affiliate became ISPE’s first multinational Affiliate and organized its first programs.
- ISPE membership reached 5,000.
- Industry leaders developed industry-wide guidance for suppliers to assist in the management and development of computer systems. The result was the first GAMP® Guide.
- At the Annual Meeting, ISPE introduced the Pharmaceutical Engineering Baseline® Guide Series with the draft of volume 1, Bulk Pharmaceutical Chemi-cal Facilities.
- In response to member demand, ISPE launched its website (ispe.org) in November.
- Sharon Smith Holston, Deputy Commissioner for External Affairs, FDA, presented the FDA Commissioner’s Special Citation to ISPE, “in appreciation of outstanding cooperation with the Food and Drug Administration in providing vital support to the industry through educational and special projects, nationally and internationally.” Bob Best accepted the award on behalf of ISPE and received the Harvey W. Wiley Medal, named for the father of the Pure Food and Drug Law.
- At the Society’s Annual Meeting, Vice President Al Gore’s Hammer Award was presented to the ISPE-FDA team that developed a list of “similar equipment” needed for efficient implementation of scale-up and postapproval changes (SUPAC) guidance for products in immediate release–solid dosage form.
- On 21 November 1997, the Center for Drug Evaluation and Research gave ISPE a special Recognition Award.
- ISPE membership reached 10,000.
- The ISPE European Office in The Hague closed.
- The first global edition of ISPEAK was published in July-August.
- ISPE staff reached 31 employees.
- ISPE acquired the GMP Institute, effective 1 January 2000, and began ISPE’s training division.
- In June, the ISPE Singapore Affiliate, the first Affiliate in Asia, was officially launched.
- The US Department of Commerce chose ISPE to offer a four-week intensive training program jointly led by the GMP Institute, consultant Dale McMillen, and the American Association for the Advancement of Science. The course provided basic knowledge and training to enable former biochemical scientists from Russia’s Novosibirsk region to shift from their current manufacturing standards to international cGMPs.
- ISPE membership reached 20,000.
- ISPE celebrated its 25th anniversary.
- Novo Nordisk A/S received the first Facility of the Year Award (FOYA), which recognized the NovoSeven pharmaceutical manufacturing facility in Hillerød, Denmark.
- In September, in cooperation with the US FDA, ISPE released a definition paper on restricted access barrier systems.
- The FDA invited ISPE to play a leading role in transitioning how the industry is regulated and the incentives being offered to companies to innovate. Specifically, the FDA asked ISPE to change its current operating procedure in several ways:
- Publish a new science-based, peer-reviewed journal.
- In collaboration with universities and the FDA, develop a training program to be used by both industry and regulators.
- Establish a certification program that sets a standard for pharmaceutical manufacturing science and technology competency.
- Work through ASTM International to establish standards that must be referenced by the FDA.
- ISPE began forming Communities of Practice (CoPs), with six CoPs announced at the Annual Meeting in November.
- Also at the Annual Meeting, ISPE received the FDA Commissioner's Special Citation in recognition of ISPE’s “outstanding commitment and many years of continued support of crucial initiatives including the drug shortage program, the Process Analytical Technology Initiative, the reform of 21 CFR Part 11, and the Risk Based Inspection Model, as well as significant contributions to preparing for training the pharmaceutical professionals of the future.”
- ISPE’s Professional Certification Commission (PCC) launched an international job analysis survey, one of the first steps to develop a professional credential for pharmaceutical practitioners.
- ISPE redesigned its website and logo.
- In March, ISPE joined forces with the University of Florida to train workers for Florida’s growing biotechnology industry.
- ISPE launched an E-Letter series based on CoPs.
- ISPE published the inaugural electronic version of ISPEAK and the premier issue of the Journal of Pharmaceutical Innovation.
- ISPE cohosted its first conference with the Parenteral Drug Association about ICH guidances.
- PCC held the first exam for the Certified Pharmaceutical Industry Professional (CPIP) credential.
- ISPE created the Product Quality Lifecycle Implementation (PQLI) initiative and held the first PQLI workshops in Washington, D.C.
- ISPE launched a new web application for its 14 CoPs.
- GAMP® 5 was launched.
- ISPE membership reached reached over 24,000.
- ISPE reorganized, with staff and cost reductions, due to the global financial crisis.
- ISPE began offering technology-based learning and social media communication with members.
- To strengthen and expand the involvement of global regulators, ISPE introduced complimentary membership for these professionals.
- ISPE started its Young Professionals (YP) initiative.
- Bob Best announced his retirement as President and CEO after 27 years of service to ISPE.
- ISPE launched a redesigned website.
- Nancy Berg became ISPE’s President and CEO.
- ISPE held its inaugural cGMP Conference, initially cosponsored by the FDA.
- The ISPE Drug Shortages Initiative began with a global survey of industry professionals about the manufacturing root causes of drug shortages.
- The Patient Initiative launched a global survey of patients to learn about their experiences with clinical trial materials.
- ISPE announced initiatives in the areas of quality metrics and breakthrough therapies.
- ISPE began a partnership with PMMI—The Association for Packaging And Processing Technologies, including developing Pharma EXPO for November 2014.
- ISPE expanded its e-learning.
- John Bournas was named ISPE’s President and CEO.
- ISPE and the Pew Charitable Trusts initiated a joint research project into drug shortages.
- GAMP® celebrated its 25th anniversary.
- The “Message from the Chair” column debuted in the September-October issue of Pharmaceutical Engineering.
- Women in Pharma® held its inaugural session at the Annual Meeting.
- ISPE held its first Biopharmaceutical Manufacturing Conference and first European Biotechnology Conference.
- ISPE introduced a website redesign in August.
- ISPE and Pew Charitable Trusts released their report, “Drug Shortages: An Exploration of the Relationship between U.S. Market Forces and Sterile Inject-able Pharmaceutical Products.”
- Pharmaceutical Engineering covered Pharma 4.0™ for the first time in the May-June issue.
- Pharmaceutical Engineering reported on the development of chimeric antigen receptor T cell (CAR-T) therapies.
- The Regulatory Steering Committee was established.
- Young Professionals representation was added to the ISPE International Board of Directors with the creation of an ex officio slot. Caroline Rocks was the first Young Professionals representative to the board.
- Pharmaceutical Engineering Online, the online version of Pharmaceutical Engineering, began publishing on the ISPE website.
- Open access for Pharmaceutical Engineering was launched.
- ISPE celebrated its 40th anniversary.
- Tom Hartman became ISPE’s President and CEO.