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Qualified Person Education Course Module A

12/13 November 2024
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Document and track your personal development - with the Continuous Professional Development (CPD) Documentation Template

To access the template for documenting and tracking your past and ongoing activities, please go here.

After filling out the form, you will be able to create and print out a PDF file.

Should Equipment Status Identification Labels be retained with the Batch Record?


Keeping equipment status identification labels with the batch record or other files is often done to provide additional confirmation during review of the record. It supports verification that certain equipment was cleaned before usage for manufacturing. But is it required?

The U.S. Food and Drug Administration (FDA) has answered this question in an Q&A Document. Assuming each major piece of equipment has a unique "Cleaning and Use Log" that is adequately retained, these "quick reference" equipment labels can be discarded according to the agency. The FDA sees "no value in the retention of such labels in addition to the required equipment log or batch record documentation. The labels serve a valuable, temporary purpose of positively identifying the current status of equipment and the material under process. Any status label should be correct, legible, readily visible, and associated with the correct piece of equipment. The information on the temporary status label should correspond with the information recorded in the equipment cleaning and use log, or the previous batch record for non-dedicated equipment."

However, as said before, it might be useful to keep these labels in a batch record. Many companies are doing so; not because it is a requirement but it is a helpful and reliable practice.


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