|Product Name:||The Batch Record|
|Our Price:||$60.00 |
|Product Weight:||0.5 lb.|
| Product Detail|
|The batch record, a documented account of manufacturing operations, is often a misunderstood or misused system. This booklet will review the regulations for batch records, evaluate the life cycle of batch record development, examine supporting documentation, compare European and US batch record philosophy, and provide a few practical guidelines for batch records.
The primary goal of this extensive 24-page booklet is to provide the reader with knowledge of how to compile and create a master batch record. The reader’s goal should be the ability to create a completed batch record that appropriately details operation activities. The batch record should be sufficiently clear and detailed that any third party reviewer could examine the document and have minimal questions. The reader should also be to obtain a product “history” that includes development and scale-up for use as a trouble-shooting tool.
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