ABSTRACT
The individual unit carton labeling is the outermost container in which a drug product is usually marketed. The regulations now require additional checking, preferably by electronic or other automated means, although visual confirmation is allowed for hand labeling operations. Some pharmaceutical operations still include in-house printing of components either online or off-line. The return of any excess labeling is permitted, provided it does not contain any lot number/expiry dates and is undamaged, that is, meeting the same specification it did upon initial receipt. Equipment calibration and qualification together with packaging/labeling operations validation are also required to be performed before commercial runs. Manufacturers and packagers are free to use any packaging system as long as the tamper-resistant standard in the regulations is met. Technologies for sealing two-piece hard gelatin capsules are available that provide evidence if the capsules have been tampered with after filling.
