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The ABC’s of Pharmaceutical Labeling

Pharmaceutical LabelingWhat’s one of the first lessons one learns as a child? The alphabet, of course! Remember those blocks with the letters on the sides? The ABC’s are so important because they are the foundation of our language and communication. Labeling pharmaceutical products also has important Foundational Blocks used to build success. Here are the ABC’s of labeling:

A – Attention to Detail
A is the first letter in the alphabet, which is the perfect position for Attention to Detail. It’s critical to have accuracy when labeling for pharmaceutical preclinical or clinical trials. The information on the label must be correct. Whether a product is being labeled, de-labeled, or re-labeled, it’s imperative that the Master Batch Record (MBR) is prepared, reviewed, approved, and then followed. Also, the right containers need to be labeled with the correct labels, in the appropriate way, with full traceability. This is especially important when labeling for a blind study. If a container is mislabeled, there could be drastic repercussions to the study including incorrect findings. Activities to improve Attention to Detail include the review of labeling processes with active Quality Assurance (QA) participation, creating process FMEA’s to identify and eliminate risk, following clear procedures for performing verification of the product and quantities through each phase of processing, and developing mistake-proof methods for tracking time out of temperature limits when labeling temperature sensitive products.

B – Be Efficient
Timeline demands for labeling projects are becoming shorter and shorter. This cannot mean that speed trumps quality with no regard for Foundation Block A. Being efficient is the best way to meet tight turnaround times and still maintain Attention to Detail. A great way to set a team up for efficiency is to develop standard processes with checks and balances, from label creation to labeled finished product. Some examples of this include upfront training of all personnel before the job starts, designing the right layout/configuration for the job in the production setting, and minimizing material handling. Having a standard process for the multiple steps involved enables efficiency, which results in meeting requirements and short timelines.

C – Careful Planning
Last, but not least, is Careful Planning. The better the job is planned, the more efficient the process execution is and the better the results will be. Good planning should occur well before a labeling job, and includes development of artwork and text, determining label size and configuration to match the containers, appropriate selection of adhesive and stock for application to the substrate, correct and legible label content, and proper room clearance. If everything is taken care of in advance, the actual execution of a job can be worry-free.

There could be a whole foundation alphabet for labeling. Starting with A, B, and C keeps this simple and efficient, mirroring how labeling projects should be for pharmaceutical products.


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Tammy Summerville

Tammy Summerville

Associate Production Manager at BioConvergence LLC
Tammy has almost 20 years of experience in the pharmaceutical industry including roles in product development, clinical and commercial manufacturing, new product launches, and supply chain management. Her experience includes performing FAT (factory acceptance test), commissioning, validation, production, safety facilitator and Device Lab. Responsibilities for device lab included formulation, milling/grinding, filling, capping, inspection, labeling and packaging. She has been in various management roles since 1998.
Tammy Summerville

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