Structure and Contents of a Batch Record (PP-PI)

The guidelines on Good Manufacturing Practices (GMP) specify that a processing record must be created for every batch. In R/3 terms, this means that the execution of the process order that was used to manufacture the batch must be logged.

When creating a batch record, the R/3 system therefore compiles all quality-relevant data collected around this process order. The data is combined in one comprehensive list that meets the GMP requirements as follows:

The following table provides an overview of:

Data in a Batch Record:

Data required according to GMP

Corresponding data sources in R/3

The relevant parts of the process specification and processing statement

Process order including material list

In-and post-process controls, initials of the person carrying them out and the results

Inspection lot for the inspection during
during production and the incoming inspection

Actual process data

Process messages and PI sheet

 

For more information about the source and archiving of various data, see the following sections:

Process Order And Material List (PP-PI)

Inspection Lots

Process Messages

PI Sheet


If you want to include more data in your batch record, you have the following options:

All files are combined in a document info record representing the header record of the batch record.