Risk-Based Inspection (RBI) – Schedule M Point 33.4 verifies “whether all the documents generated during batch production are attached with the BPR/BMR.” CDSCO Under RBI, this is a high-priority documentation control because missing attachments weaken traceability, investigation quality, and batch release decisions—and can hide contamination, mix-up, or data-integrity issues.
What “documents generated during batch production” typically includes
Inspectors expect the executed Batch Production/Manufacturing Record (BPR/BMR) to contain (or clearly reference with controlled annexure numbers) all contemporaneous evidence produced during the batch, such as:
- Dispensing/issuance sheets for each raw material and primary packing material (as applicable), including verification signatures.
- Equipment use logs and relevant cleaning/line clearance records for the equipment/area used in the batch.
- In-process control (IPC) sheets: blend uniformity checks, granulation endpoints, compression parameters, weight variation, hardness, friability, coating parameters, etc.
- Environmental/utility monitoring records relevant to the batch (e.g., compressed air/water where applicable) and any critical area monitoring summaries. PIC/S expects QC-related data including environmental monitoring and test records to be available and retained with batch documentation principles.
- QC raw data package linked to the batch: worksheets/notebooks, instrument printouts, chromatograms, calculations, and approvals; PIC/S states QC documentation relating to a batch record should be retained and raw data readily available.
- Deviation/investigation reports raised during processing, along with impact assessment and CAPA references.
- Any rework/reprocess records (if applicable) and approvals.
How RBI inspectors check compliance with 33.4
They usually pick recently released batches (and higher-risk products first) and test:
- Is there a defined “batch record annexure list” in the master record (so nothing is forgotten)?
- Are attachments complete, legible, signed/dated, and traceable (page numbering, cross-references, controlled forms)?
- Do QA reviewers actually verify completeness before release, and are missing documents treated as deviations?
A strong 33.4 system produces a single, review-ready batch dossier that proves the batch was made and controlled exactly as intended.