Product Label Identification – Needs and Risks 

A contract manufacturing organisation (CMO) was chosen by a Sponsor, to process some API material with excipient to produce an intermediate which would then be used for bulk drug product manufacture. The processing of the API was a success, however, the information presented in the final container label, including the product description, was coded and not in a format that could be clearly understood by the receiving party. 

The label generated for the final container used a predefined template for internal labelling, and the product name was presented in a manner recognisable only to the CMO. Key information such as sponsor name and study code were not part of this template. Problems with the label were only recognised following receipt of the intermediate at the IMP manufacturing site.   

JWQC facilitated the discussion between the sponsor, the CMO providing the intermediate, and the receiving CMO, to mitigate the risks associated with potential mis-identification of the product. Corrective actions were implemented to ensure that all label specifications would be agreed as part of setting up the product’s Technical Reference File.   

JWQC improved sponsor awareness of label requirements and worked with the client to improve their processes to ensure all labels, for any product type, are agreed up front and meet the requirements of the receiving party.