RISK BASED INSPECTION [SCHEDULE M-POINT (34.16)]

In a risk-based inspection (RBI), Schedule M point 34.16 checks a high-impact documentation risk: whether the Batch Production Record (BPR) is based on the current, approved Master Formula Record (MFR). If an outdated MFR is used, the batch may be manufactured with wrong quantities, steps, IPC limits, equipment, hold times, or special precautions—leading to OOS results, stability failures, cross-contamination, mix-ups, and patient harm. The CDSCO benchmark checklist states this requirement explicitly: “Whether BPR are based on current master formula record.” CDSCO

What inspectors verify (RBI depth):

1. One “source of truth” MFR: a formally authorized master formula exists for each product and batch size, with complete stepwise instructions, IPCs, yields, equipment and special precautions.
2. Version control & issuance: the BPR template used for the batch is printed/generated from the latest effective MFR; obsolete versions are withdrawn; controlled copies are issued by QA/Documentation.
3. Change control linkage: any MFR change (formula, process parameters, IPC limits, equipment, cleaning instructions, sampling points) is approved through change control and is reflected in the next BPR revision, with effective dates and training evidence.
4. Batch start controls: before manufacturing starts, the line verifies BPR revision number vs MFR revision number and records the check; any mismatch triggers deviation and batch hold.
5. Data integrity and traceability: entries are contemporaneous, attributable, and legible; corrections follow GDP; electronic systems have audit trails and access control.
6. Batch record review effectiveness: QA review confirms that any deviation from the master formula is documented, scientifically justified, and authorized, and that trends trigger CAPA. WHO GMP expects deviations from the master formula to be documented with signed authorization in batch records.

Common RBI red flags: BPR printed from an old file folder, uncontrolled photocopies, mismatched revision numbers, undocumented “field changes,” and repeated deviations indicating the master formula itself is not kept current.