Batch documentation – Pharmaceutical Manufacturing


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Here you will find answers to the following questions:

  • What must the manufacturing instructions/batch processing record contain?
  • Example: Manufacturing instructions/record
  • What must the packaging instructions/batch packaging record contain?
  • What does the expression “Electronic Batch Recording System” mean?
  • What must a testing procedure contain and how must it be organised?
  • What does a test protocol contain? How must raw data be handled?
  • What is a BRR and what is its purpose?
  • How can the BRR be documented?

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:






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