Electronic Batch Record (EBR)
The Electronic Batch Record (EBR) includes the complete set of evidences documenting the whole manufacturing process history including packaging and quality controls.
It allows to:
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reconstruct in its integrality the complete set of manufacturing, packaging and quality control process sequences.
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make sure that all process steps have actually been completed according to the written manufacturing and packaging instructions
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male sure that the final results, that's to say the medicine, is conformig to the filed specification.
The EBR file must be archived and easily accessible.
Items of an EBR file:
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Product designation :
name, pharmaceutical form, dosage -
Finished product batch ID
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Start & finish date/time of production process
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Complete quantitative and qualitative formulation
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Batch ID or control number of each material that is used in the manufacturing process as well as, when applicable, those of the primary packaging materials.
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Record of the results of the controls and verifications made during the manufacturing process
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Actually achieved process efficiency as compared to the expected process efficiency at the final stage, and if relevant at intermediate stages
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Duly signed records of all sequences of the process with description of the taken precautions and remarks made during the manufacturing
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Date and signature of the production manage
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