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MBR and Exports

Download the Master Batch Record (MBR) PDF and JSON exports from Clarix for regulatory filing and long-term archiving.

MBR and Exports

After a batch is released, Clarix generates a complete Master Batch Record (MBR) — the official electronic production record required for 21 CFR Part 211 compliance. The MBR is available for download as a formatted PDF and as a machine-readable JSON archive.

What is the Master Batch Record?

The Master Batch Record (MBR) is the complete documented history of a single batch. For 503B outsourcing facilities, the MBR is a regulatory requirement — it must be retained for at least three years (or per your state board's requirements) and must be available for FDA inspection on demand.

Clarix's MBR is a self-contained document that can be read without access to the Clarix system, making it suitable for long-term archiving, off-site storage, or submission to regulators.

What the MBR contains

A complete Clarix MBR PDF includes the following sections:

Batch header

  • Facility name and address
  • Batch number (e.g., BN-2026-0001)
  • Master Formula number and version (e.g., MF-2026-0003 v2)
  • Product name and strength (e.g., Famotidine 20 mg/mL Injection)
  • Batch size and unit (e.g., 2,500 mL)
  • Scheduled and actual production dates
  • Beyond-Use Date (BUD)

Personnel

  • Compounding technician name and credential
  • QA Officer reviewer name and approval timestamp
  • Pharmacist-in-Charge (PIC) name, license number, and release timestamp

Bill of Materials (BOM)

For each component:

  • Material name and compendial grade (e.g., Famotidine USP)
  • Target quantity from the formula
  • Issued lot number (linking to inventory)
  • Manufacturer lot number and manufacturer name
  • COA assay percentage
  • Actual quantity issued
  • Expiry date

Step records

For every step in the batch (in sequential order):

  • Step number and name
  • Step type
  • Instructions (as written in the formula)
  • Technician's recorded response or measurement value
  • Acceptance criteria (if applicable)
  • Pass / Fail status
  • Technician name and electronic signature
  • Timestamp

For special step types:

  • Verification steps — both technician and verifying person are listed
  • Signature / RPh gate steps — signing pharmacist, role, and timestamp
  • Calculation steps — expression used and computed result
  • Barcode scan steps — scanned value and validation result
  • Timer steps — start time, configured duration, and actual elapsed time

Worksheets

  • In-process control records (all fields)
  • Particle count data or PDF attachment
  • Visual inspection results
  • Label reconciliation (printed, applied, spoiled, destroyed, remaining)

Yield

  • Theoretical yield (from formula)
  • Actual yield (entered by technician)
  • Yield percentage with pass/fail against threshold

Amendments

  • Any step corrections with original value, corrected value, reason, and approver

Signatures page

  • QA Officer electronic signature block with date, time, and IP address
  • PIC electronic signature block with date, time, and IP address
  • Regulatory statement: "I certify that this batch was compounded in accordance with the approved Master Formula and applicable USP and FDA requirements."

Downloading the MBR PDF

Role required: Any role with batch read access (Viewer or above).

  1. Open the batch detail page for any Released batch.
  2. Click the Download MBR button in the page header.
  3. The PDF is generated on demand and downloaded to your computer.

The PDF is formatted for standard letter or A4 paper and includes page numbers, a header with the batch number on every page, and a footer with the generation timestamp.

Downloading the JSON export

The JSON export is a machine-readable archive of all batch data — useful for:

  • Long-term archiving in a document management system
  • Integration with regulatory submission software
  • Data analysis or migration to a future system
  1. Open the batch detail page.
  2. Click Export JSON (available from the batch actions menu or the same header area as the MBR download).
  3. A .json file is downloaded.

The JSON export contains all the same data as the PDF, structured in a documented schema. Contact your Administrator or Clarix support for the export schema specification.

Downloading the Custom EBR PDF

Role required: Any role with batch read access (Viewer or above). Requires an approved EBR Document Template in Settings.

In addition to the standard MBR, Clarix can generate a Custom EBR PDF using your facility's branded template — with custom headers, footers, cover pages, and layout, built in the visual EBR Template editor.

  1. Open any batch detail page (any lifecycle state).
  2. Click Download Custom EBR in the page header or actions bar.
  3. Clarix finds the approved EBR Document Template for this formula (or the org-wide default if no formula-specific template exists).
  4. The PDF is generated using the template layout and populated with live batch data and merge fields.
  5. The file downloads to your computer.

Custom EBR vs. MBR: The standard Download MBR always uses Clarix's built-in compliance layout and is always available for Released batches. The Custom EBR uses your branded template and can be generated at any lifecycle stage, but requires an approved EBR Document Template to be configured first.

To create or manage EBR Document Templates, go to Settings → EBR Document Templates. See EBR Templates for a full walkthrough.

Bulk PDF export

To download MBRs for multiple batches at once:

  1. Go to the Batches catalog.
  2. Select the batches you want to export using the row checkboxes.
  3. Click Export PDFs in the Bulk Actions bar.
  4. Wait for generation to complete.
  5. A ZIP file is downloaded containing one PDF per batch, named by batch number.

See Bulk Actions for more detail.

Archiving requirements

Per 21 CFR Part 211.188, batch production and control records must be retained for at least one year after the expiration date of the batch, or at least three years after distribution — whichever is longer. Consult your compliance officer for the specific retention requirements applicable to your facility.

Clarix retains all batch data indefinitely within the platform. For additional off-site archiving, we recommend downloading the MBR PDF and JSON export after each release and storing them in your document management system.

Bulk Actions

Multi-select batches in the catalog to quarantine, reassign technicians, or export PDFs in bulk.

EBR Document Templates

Customize the header, footer, and cover page of your Electronic Batch Record PDFs using the visual template editor.

On this page

MBR and ExportsWhat is the Master Batch Record?What the MBR containsBatch headerPersonnelBill of Materials (BOM)Step recordsWorksheetsYieldAmendmentsSignatures pageDownloading the MBR PDFDownloading the JSON exportDownloading the Custom EBR PDFBulk PDF exportArchiving requirementsRelated pages