Batch manufacturing record in pharmaceutical industry


globalcompliancepaneltraining

A batch manufacturing record in pharmaceutical industry is information relating to the product and batch. It is a document that is intended to give a full and authoritative record of the manufacturing history of each batch of every product. The FDA defines a batch thus: “A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture”.

System of checkpoints

In the light of this definition, batch manufacturing record in pharmaceutical industry has to be understood as one that is basically based on the master formula record. It is created, checked, ratified and sanctioned by the designated, competent technical person/s that is responsible for the organization’s production and quality control.

In order to avoid wrongful reproduction, batch manufacturing record in pharmaceutical industry involves use of methods…

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