Standards and Legal Requirements (PP-PI)
In the Good Manufacturing Practices for Pharmaceutical Products (GMP), one of the main requirements stated with regard to documenting the production process is that "A batch processing record should be kept for each batch processed."
GMP guidelines were originally drafted by the Food and Drug
Administration (FDA) of the United States and are legally binding
for the pharmaceutical industry there.
Over the last two decades, these guidelines have also become an internationally accepted standard regulating the manufacture of pharmaceutical products. They were adopted and revised by the World Health Organization (WHO), which also initiated a certification scheme for pharmaceutical products based on GMP. Other documents and agreements like the ASEAN good manufacturing practices guidelines (1988), the Good manufacturing practice for medicinal products in the European Community (1992) and the Pharmaceutical Inspection Convention also contributed to the dissemination of GMP guidelines. These have now become law in many other countries as well.
The batch record of the R/3 System is based on the GMP guidelines and meets the GMP requirements a processing record must fulfil. For more information on how the requirements have been implemented in the R/3 System, see the following sections:
Structure and Contents of a Batch Record (PP-PI)
Process: Batch Recod Archiving (PP-PI)