Excipient GMP Training for Distributors? Done!

News category: 
Wednesday, August 17, 2016

IPEC-Americas Excipient Learning Lab launched its first three eLearning courses in July and they’re off to a great start!

The courses were beta-tested by several excipient distributors as well as excipient manufacturers. EVERYONE who has taken the course (beta testers and attendees who have paid for the course) would “recommend or strongly recommended the course to my colleagues”.

Check out this 7-minute preview to see if the courses are right for your organization:

  • Level 1 Excipient GMPs for Manufacturing Workers – Production & Maintenance
  • Level 1 Excipient GMPs for Manufacturing Workers – Warehouse/Bulk Handling
  • Level 1 Excipient GMPs for Manufacturing Workers – Laboratory

Don’t let the names fool you – these courses are just right for IPEC-Americas excipient distributors, too.

Distributors who take ownership and possession of excipients and resell them in the manufacturer’s sealed packaging (“closed-container distributors”) can well benefit from the “Warehouse/Bulk Handling” version. These distributors have the same GMP requirements for the storage and shipment of excipients as does the excipient manufacturer.

Distributors who repackage and retest excipients from other manufacturers for resale are considered manufacturers themselves for regulatory purposes, even if they resell them with the authorization and branding of the original manufacturing. As a result, all three of the above eLearning courses are appropriate. 

The three courses all have introductory informational sections on excipient definitions and use along with an overview of GMP history. While these sections are not required learning for excipient GMPs, they give workers some context to understand how their company’s products are used, fit into the pharmaceutical industry overall and can help keep medicines safe for patients, who might also be themselves, family members, and friends.

All the courses also have required-learning sections on Documents and Records, Hygiene, and Work Environment. These topics apply to all types of distributors to varying degrees.

The Warehouse/Bulk Handling edition has a detailed section on GMP expectations for workers in shipping/receiving, and other warehouse / tank farm operations. It’s easy to see how it is relevant for a closed-container distributor. 

For distributors who repackage and retest excipients made by other manufacturers, the Production & Maintenance and Laboratory versions are a good way to get employees trained quickly and conveniently in excipient GMPs. And of course, the Warehouse/Bulk Handling version is relevant for this type of distributors as it is for closed-container distributors.

IPEC-Americas knows that distributors come in all sizes – local (small), regional (medium) and national/international (large), so we’ve designed our eLearning to be relevant, convenient, efficient and affordable for all three.