WHAT WE DO
ISPE's Core Members are pharmaceutical professionals who use expert knowledge to create high-quality, cost-effective GMP solutions.
Our Baseline® Guides are relied on globally by industry and regulators to define the industry standards for design, construction, and operation of pharmaceutical manufacturing facilities. ISPE’s training, conferences, and Knowledge Networks give professionals solutions for their needs and connect them with other professionals to share best practices. We know how to design, build, qualify, license, operate, and maintain these complex facilities, including those that manufacture active pharmaceutical ingredients, finished dosage forms, delivery systems, and packaging. Through ISPE's branded expertise in these areas we have deep technical knowledge that is applied in a practical manner.
We lead and facilitate the development of next generation process technologies and innovative technical solutions. On matters of regulation, our focus is on those requirements that impact — or will impact — the licensing of facilities, manufacturing processes and operations, and the sustainability of the supply chain over the product lifecycle. We have developed relationships with and continue to provide key access to major regulatory agencies at the most senior levels.
ISPE aims to offer increasing and unparalleled value for Members, companies, and stakeholders globally and across all constituent parts of the industry. The end result will be the continued improvement and transformation of the pharmaceutical manufacturing industry to better ensure the availability of quality medicines to patients around the world.
Our Purpose: ISPE delivers technical and operational solutions to support our Members across the global pharmaceutical and biopharmaceutical industry in the manufacture of quality medicines for patients.
WHO WE ARE
ISPE, the International Society for Pharmaceutical Engineering, was founded in 1980 by a handful of people who believed the pharmaceutical industry needed an organization that would deal with practical applications of science and technology for technical professionals.
The much-needed forum provided by ISPE began with a membership of engineers in North Africa. In time, ISPE membership expanded beyond engineering to include a broad representations from pharmaceutical professionals.
We are the largest not-for-profit association providing technical and regulatory support to members throughout the entire pharmaceutical lifecycle. Our 19,000+ members, located in more than 90 countries around the globe, are dedicated to the development and manufacture of safe and effective pharmaceutical and biologic medicines, and medical delivery devices.
Malaysia has long since been a leading producer of quality small molecule pharmaceuticals. Recent efforts by the government to position Malaysia as a regional center for the manufacturing of large molecule biopharmaceuticals are showing considerable promise. In order to ensure Malaysia’s appeal as a center for research, development and manufacturing of therapeutic products continues to intensify, we realize that there is a need to nurture and develop locally-based industry professionals in the pharmaceutical engineering field.
In the past, we Malaysians have been forced to travel to Singapore and other parts of the world in order to take part in ISPE-organized events. This has proven cost prohibitive for many companies and has, in effect, acted as a limiting factor in the development of Malaysia’s human capital in life sciences industry. The establishment of the ISPE Malaysia Affiliate will bring a significant increase in opportunities for the development of locally-based industry professionals. It will provide a conduit to ISPE members throughout the world and a local center that is able to address the challenges facing the local needs of our growing industry. The ISPE Malaysia Affiliate is here for small, medium, and multinational companies operating in the pharmaceuticals, healthcare, medical devices, and related industries.
In line with this objective, a team of 15 individuals from Malaysia; representing the pharmaceuticals and healthcare industry, regulators, government agencies, and academics; formed a Steering Committee to formulate and implement the necessary steps to form a Malaysia Affiliate of the ISPE International. This eclectic and balanced combination of related professions represents the full body of knowledge relevant to the industry and necessary for its innovative development.