QA Review and PIC Release

This workflow covers the final quality gate before a batch is released — from the moment a technician submits the completed batch record through QA Officer review, exception handling, and PIC electronic signature. A rigorous review and release process is a cornerstone of 503B compliance.

Process overview

Step 1 — Batch submitted (Mark Complete)

Role required: Batch Technician

1. All steps in the batch must be in Completed status before submission.
2. Navigate to the open batch and click Mark Complete.
3. Clarix validates that:
   • No steps are in a pending or in-progress state
   • All required witness signatures are present
   • Yield has been calculated
4. If validation passes, the batch status changes to Completed and then immediately to Pending QA.
5. The batch is now locked for editing by the technician (amendments require the QA Officer's involvement).

Step 2 — QA Officer receives notification

Role required: QA Officer

1. The QA Officer receives an in-app notification and email (if configured) that a batch is pending review.
2. Navigate to Batches → Pending QA to see all batches awaiting review, sorted by submission time.
3. Each batch card shows the batch number, formula, technician, submission time, and any open deviation flags.

Step 3 — QA reviews batch record

Role required: QA Officer

1. Open the batch from the review queue.
2. Review the following systematically:
   • Steps — verify each step was completed as specified, check recorded values against limits
   • Calculations — confirm yield, potency, and any in-process calculations
   • Worksheets and attachments — review raw data sheets, printouts, and photos
   • Deviations — check that all linked deviations are in an appropriate state (closed or documented)
   • Equipment — confirm all instruments used were within calibration during the batch
   • Lot traceability — verify all component lots are released and quantities reconcile

Step 4 — QA approves or flags

Role required: QA Officer

If the batch record is complete and correct:

1. Click Approve. The batch advances to Awaiting PIC.
2. The PIC receives a notification immediately.

If issues are found:

1. Click Return to Technician and enter detailed comments describing what needs to be corrected.
2. The batch status returns to a correctable state and the technician is notified.
3. The technician makes amendments (GDP-compliant, with reason and signature) and resubmits.

Step 5 — Review by exception

Role required: QA Officer

When a batch has an anomaly that does not prevent release but must be documented:

1. In the batch review screen, click Add Exception Note.
2. Describe the anomaly and the scientific or procedural rationale for approving despite it.
3. The exception note is attributed to the QA Officer with a timestamp.
4. Click Approve with Exception. The exception is included in the MBR PDF.

Note: Review by exception is not a substitute for opening a deviation when one is required by SOP. Exception notes document acknowledged anomalies; deviations document out-of-specification events requiring investigation.

Step 6 — PIC receives notification

Role required: PIC (Pharmacist-in-Charge)

1. The PIC receives an in-app notification and email (if configured) that a batch is awaiting release.
2. Navigate to Batches → Awaiting PIC to see all batches pending the PIC signature.

Step 7 — PIC reviews and signs release

Role required: PIC (Pharmacist-in-Charge)

1. Open the batch record.
2. Review the QA-approved record, yield summary, component lots, and any exception notes.
3. Verify that all quality checks are satisfied and the batch is suitable for dispensing.
4. Click Release Batch.
5. Clarix prompts for the PIC's electronic signature:
   • Enter credentials (username and password or biometric, per facility configuration)
   • Select the meaning of signature: "I approve this batch for release"
   • Confirm
6. The batch status changes to Released.
7. Clarix immediately generates the MBR PDF and attaches it to the batch record.

Step 8 — MBR generation

1. After release, navigate to Batch → Exports.
2. Download the MBR PDF, which includes:
   • All completed steps with recorded values and signatures
   • Component lot traceability
   • Yield summary
   • Deviation references and exception notes
   • QA and PIC electronic signature blocks with timestamps
3. Store per your document retention SOP.

Edge cases

Related pages

• QA and PIC Release
• Review by Exception
• MBR and Exports
• Batch Lifecycle