Subpart J recordkeeping requirements: batch records, complaint files, reserve samples, and returned or salvaged product handling.
This module covers Subpart J: general requirements for records retention and annual product review under 211.180, batch production and control record requirements under 211.188, complaint file requirements under 211.198, reserve sample requirements, and the handling of returned and salvaged drug products.
Recordkeeping is the subpart that every other Part 211 requirement ultimately depends on, since without a complete, contemporaneous record, there is no way to demonstrate that any other requirement was actually met.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
Start this course →