The FDA has approved the first ever drug created via 3D Printing technology, a decision which can lead to a new era of drug manufacturing. The drug controls seizures called Spritam, manufactured by Aprecia Pharmaceuticals. FDA have also approved medical devices created through 3D printing in the past.
Spritam is made out of a porous formulation utilising 3D printing which the company claims that it “rapidly disintegrates with a sip of liquid.” Such a technique would help children and elderly patients to facilitate adherence towards medication.
Such technology would require validation to make sure that it is fit for its intended purpose. After all, it is producing a drug which undoubtedly has the question of patient safety with it.
KVALITO AG is a leading Life Science Sector consultancy, which helps companies quickly and easily whilst ensuring compliance with the ever-growing list of regulatory requirements for different types of validation.
Author: KVALITO Consulting Group
