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.
ISPE Malaysia Affiliate was established in January 2012 by a group of industry leaders who believed the Malaysian pharmaceutical industry needed an organization and platform that would deal with practical applications of scientific and technical knowledge for our industry professionals. Since then, ISPE Malaysia membership has expanded not only among the pharmaceutical industry but also other professionals and areas of interest as well.
Our members consist of professionals in the pharmaceutical and healthcare industry, suppliers, regulators, government agencies, academia and students. This diverse mix represents the healthcare ecosystem in Malaysia and provides a balanced view of the knowledge and skills needed to drive Malaysia towards being a key player in the development and manufacture of safe and effective medicines.
ISPE Malaysia Affiliate also aims to serve as a platform to bring our members closer, sharing good practices, technical updates and knowledge with each other locally as well as through our international network of 18,000 strong members in more than 90 countries around the world. Every year, we have an exciting calendar of education training events, networking opportunities and virtual conferences planned that will provide valuable information in key strategic areas for our members.
Office address: Suite 8.01, Level 8, Menara Binjai, No. 2, Jalan Binjai, 50450 Kuala Lumpur.
Tel: +(60)3-2386 7730
Fax: +(60)3-2386 7711