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A unique identifier assigned to a specific production batch of a drug product, essential for quality investigations and potential recalls.
A cluster of adverse events is reported. By capturing batch numbers, the company identifies all cases involve the same batch, triggering a quality investigation that reveals a manufacturing deviation.
21 CFR 211, EU GMP Annex 11
Not attempting to collect batch numbers for serious or unexpected events where quality issues could be involved.
How do you attempt to collect batch information? What is your follow-up procedure when batch is missing from serious reports?