Why The ISPE And Their Guidelines Matter
The ISPE describes itself on its website: www.ispe.org, as ”the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.”
More simply: The ISPE is an acronym. That acronym stands for the International Society of Pharmaceutical Engineers. So, to our pharma people out there, listen up!
If you are involved in pharmaceutical research or manufacturing you, your company, or someone you know is most likely an ISPE member. The ISPE is different from other acronyms the pharmaceutical world may be familiar with (like FDA, for example) because it is not a government regulation or an accreditation bureau. Instead, they are an international hub for pharmaceutical knowledge. That’s pretty useful for pharmaceutical professionals.
Which is why you should care. They say knowledge is power. And the ISPE has A LOT of knowledge. The organization has been around since 1980, and for the last 35 years, has been gathering and distributing knowledge to the pharmaceutical world. They have developed a magazine, sponsored multiple conferences, created legitimate publications, and provided training courses for any and all of their members. Basically, they are a powerhouse.
For us here at Dickson, the ISPE is important because of the Guidance Documents they generate on temperature monitoring and cold chain management. Their GAMP (Good Automated Manufacturing Practice) guidelines on validating automated systems has informed our own knowledge of proper ways to validate our own systems, and how we can best help our customers validate their systems using our products. Plus, their Good Practice Guide for Cold Chain Management has been a legitimate resource for us since its creation in May of 2011, especially in our knowledge of temperature mapping as it applies to sensor location.
That’s just one small example of the ISPE’s reach. For pharmaceutical manufacturers, they are an essential resource for knowledge. If you don’t know about them by now, you should.