Given that serialization execution is new to many in the industry, what should drug developers look for when reviewing a new contract development and manufacturing organization (CDMO) that will be manufacturing serialized product or when approaching the project with existing CDMOs?
Performing a gap analysis of existing CDMOs or potentially new relationships is essential to understanding who in the network is ready for serialization, and where additional expertise might be needed. Some of the questions to be considered include:
Do they have experience implementing serialization programs?
Has the CDMO already developed a strategy for serialization?
Do they have robust serialization implementation plans?
Do they have a dedicated serialization team that can help guide you through the execution process?
What is their overall serialization capacity?
What types of product formats is the CDMO able to serialize?
Which software vendors are they using, and are they compatible with your existing EPCIS system?
Do they have IT expertise that will address escalating needs as track and trace is implemented?
Can they assist you in optimizing the three variables in packaging and artwork – graphic/artwork placement, package structural design, and the potential impact/interface on the line equipment/processing equipment – required to support serialization?
Is the executive management of the CDMO in question fully supportive of their firm’s serialization service offering initiatives?
Are updates to an existing quality agreement required to accommodate serialization needs?
Does the CDMO in question have the capital investment resources to ensure the timely implementation of serialization capabilities?