Iso 15378 Key Pointspdf Portable Free -

: Mandatory lot-level tracking systems to trace a batch from raw starting materials through final distribution. Process Validation

Unlike pure QMS standards, ISO 15378 requires for packaging:

To meet the standard, organizations typically maintain a "Documentation Kit" that includes: Aligned with ISO 9001 and GMP.

Mandatory validation for critical activities like cleaning, sterilization, and automated inspection.