16.11.2020

How do you ensure the traceability of the batch documentation?

To ensure the traceability of the batch documentation,
• make sure independent verification of traceability, e.g. in the context of self-inspections.
• check consistency with other documents, including process validation, validation of holding times, media fills, clean and dirty hold times.
• in particular, ensure the traceability of the chronological order and reconciliation.

[GMP Compliance Adviser, Chapter 21.C]