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All tasks relevant to the manufacturing, packaging and checking of medicinal products can be traced via the batch documentation. This is particularly important if quality problems occur that did not exist or were unknown at the time the medicinal product was approved for sale. In terms of product liability, a properly compiled batch documentation is often the only means at the disposal of the pharmaceutical manufacturer for providing evidence (see chapter 1 Quality Management). This not only underscores the importance of compiling GMP conforming documentation, but also emphasises the necessity for appropriate subsequent handling.
Example of a batch record: