How to Run GMP Batch Release Documentation That Passes WHO and KEBS Audits

Who this is for

You manage quality at a pharmaceutical manufacturer or medical device company. Batch release documentation is currently physical — folders, sign-off sheets, manual routing between QC and Regulatory Affairs. You're preparing for a WHO prequalification inspection or KEBS GMP certification. And you know that a missing signature on a critical control point, or a batch record that takes 20 minutes to locate, is the kind of finding that delays the entire review.

What you can achieve

• Every batch moves through a documented, sequential release workflow — no step can be skipped, no step can be retroactively completed after the fact
• QC and Regulatory Affairs approvals are captured at the moment of the actual decision — with role attribution and tamper-evident timestamps that an auditor can verify
• Any batch record is retrievable in full in under two minutes — for an inspector, a recall coordinator, or a regulatory query at any point in the product's life cycle
• WHO prequalification inspectors see a systematic digital GMP compliance record across all reviewed batches — no missing signatures, no manual retrieval delays
• Environmental monitoring data and deviation records are embedded in the batch record itself, not sitting in separate folders that need to be cross-referenced
• Batch release cycle time drops when QC and RA approvals happen in the workflow rather than waiting for a physical file to be routed between offices

The workflow in Hakiki

1. 1
   Certificate of Analysis UploadFile upload

   Upload completed CoA from QC laboratory — all parameters must be within specification before upload

2. 2
   All In-Spec Results ConfirmedYes or no

   QC analyst confirms all CoA parameters are within specification — required before QC Manager sign-off

3. 3
   QC Manager Sign-OffYes or no

   QC Manager confirms batch passes quality criteria — with Manager ID and timestamp

4. 4
   Label Artwork PhotoFile upload

   Photo of printed batch label showing batch number, expiry date, and product name — verified against BOM

5. 5
   Batch & Expiry Confirmed on PackYes or no

   Confirm batch number and expiry date on physical pack match the batch record — manual verification

6. 6
   Pack Count Matches BOMYes or no

   Confirm unit count per case matches the Bill of Materials specification

7. 7
   Clean Room TemperatureText

   Enter manufacturing environment temperature (°C) during production — GMP environmental monitoring

8. 8
   Relative HumidityText

   Enter relative humidity (%) during production — required for GMP documentation of environmental conditions

9. 9
   Differential Pressure LogFile upload

   Upload differential pressure log for the manufacturing suite — confirms cleanroom integrity

10. 10
    All Deviations DocumentedYes or no

    Confirm any production deviations have been raised, investigated, and documented before release

11. 11
    Regulatory Affairs Release AuthorizationYes or no

    Regulatory Affairs confirms batch is cleared for distribution — final release gate with RA ID and timestamp

Hakiki features used