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Frequently Asked Questions about Batch Records

Schniepp, Susan J

Pharmaceutical technology Europe, 2022-12, Vol.34 (12), p.34-34 [Periódico revisado por pares]

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Título:
Frequently Asked Questions about Batch Records
Autor: Schniepp, Susan J
Assuntos: CFR ; Investigations ; Manufacturing
É parte de: Pharmaceutical technology Europe, 2022-12, Vol.34 (12), p.34-34
Descrição: QCan I release a batch record that has open investigations/ ¦ deviations associated with it? A The regulation, US 21 CFR 211.22(a), states, "There shall o be a quality control unit that shall have the responsibility and authority to approve or reject... drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated" (1). [...]there is too much risk associated with releasing a product to the field with open investigations or deviations because, if the investigation result indicates the product has not achieved the specified quality attributes, by releasing it you have not only risked patient safety but you are facing a recall situation. The review should confirm that all the materials used were appropriately discharged using calibrated equipment in a suitable environment and that the manufacturing rooms were properly cleaned and cleared before the start of the batch.
Editor: Monmouth Junction: Intellisphere, LLC
Idioma: Inglês

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