Document ID: OG-WIN-PROD-BPR-REC
Version: 1.0
Last Change Date: 2026-02-26
WIN Execution Guide — Batch Production Record (BPR) Compilation
Non-Authoritative WIN Execution Guide Notice
This WIN Execution Guide supports execution of applicable Family Pack controls.
Authority for control intent and requirements remains solely with the
governing Family Pack. This document does not create, modify, or interpret controls.
Purpose
To support structured compilation, verification, and reconciliation of all
batch execution documentation prior to Quality Assurance (QA) review.
Scope
Applies to all completed production batches requiring compilation of
execution records, reconciliation documentation, deviation linkage,
and confirmation of ALCOA+ compliance prior to QA disposition review.
Section 6 — AA (Auditable Artifacts)
AA-PROD-BPR-REC — Batch Production Record
- Compilation of all execution records
- Documentation of deviations or exceptions
-
Reconciliation of components, labels, packaging materials (where applicable),
and theoretical versus actual yield in accordance with 21 CFR 111.260(e),
including investigation of unexplained discrepancies
- ALCOA+ compliance confirmation
- Readiness confirmation for QA review
Auditor focus: Completeness, traceability, and linkage to Quality disposition.
QC-REQ Anchor: QC-REC-002
Section 7 — WIN (Work Instructions / Control Requirements)
WIN-PROD-BPR
- Compile all execution records.
- Verify completeness and ALCOA+ compliance.
- Confirm reconciliation documentation.
Stop-Execution Condition:
- Missing execution records
- Incomplete IPC documentation
- Undocumented deviation identified
Control outcome: Batch documentation is complete prior to QA review.
Process: Production (PROD)
Business Process Owner: Production BPO
Primary Systems / Forms: BPR-REC-01 (or controlled batch record system)
BPO-Owned Execution Zone — Operational Step Sequence
Upon completion of batch manufacturing activities, Production compiles
all required execution documentation and verifies completeness prior
to submission to QA for review and disposition.
Step 1 — Compile Execution Records
- Assemble all batch execution documentation, including blending, filling, IPC, pre-weigh, and related records.
- Confirm inclusion of equipment logs, monitoring data, and attributable entries.
- Ensure documentation is organized in chronological order.
Step 2 — Verify Completeness and ALCOA+ Compliance
- Confirm all required fields are completed.
- Verify entries are attributable, legible, contemporaneous, original, and accurate.
- Confirm corrections (if any) follow approved documentation practices.
- Ensure no blank or unexplained gaps remain in the record.
Step 3 — Confirm Reconciliation Documentation
- Verify reconciliation of components, labels, and packaging materials where applicable.
- Confirm theoretical versus actual yield comparison is documented.
- Ensure any unexplained discrepancy has documented investigation reference.
Step 4 — Verify Deviation and Exception Linkage
- Confirm all deviations or exceptions are documented.
- Ensure linkage to escalation, investigation, or quality event reference numbers.
- Verify corrective actions or interim controls are recorded where applicable.
Step 5 — Confirm Readiness for QA Review
- Document readiness confirmation for QA review.
- Obtain required production supervisory verification.
- Transfer completed BPR package to QA per controlled workflow.
Stop-Execution Principle
If execution records are missing, IPC documentation is incomplete,
reconciliation is not supported, or deviations are undocumented:
STOP — DO NOT SUBMIT TO QA — ESCALATE — DOCUMENT
Authority Reminder
This document supports execution only and is non-authoritative.
The governing Family Pack remains the sole source of control intent and requirements.