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.
The Problem
Paper batch records with missing signatures at critical control points are a GMP inspection finding — not a minor observation. When batch release documentation is stored in physical folders and requires manual retrieval, the risk of gaps is structurally embedded in every release. A signature that wasn't obtained at the right time, by the right role, is a deviation that has to be explained to an auditor. When it happens repeatedly, it's a systemic finding. In a product recall, the stakes are different. Every hour spent locating batch records is an hour of regulatory exposure, distribution risk, and potential public health liability. If a specific batch's complete release record can't be retrieved within minutes, the recall process itself becomes a compliance failure. Regulators don't draw a meaningful distinction between "we couldn't locate the record quickly" and "the record doesn't exist" — the operational consequence is the same.
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 immutable 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 Hakiki Workflow
- 1Certificate of Analysis Upload File Upload
Upload completed CoA from QC laboratory — all parameters must be within specification before upload
- 2All In-Spec Results Confirmed Boolean
QC analyst confirms all CoA parameters are within specification — required before QC Manager sign-off
- 3QC Manager Sign-Off Boolean
QC Manager confirms batch passes quality criteria — with Manager ID and timestamp
- 4Label Artwork Photo File Upload
Photo of printed batch label showing batch number, expiry date, and product name — verified against BOM
- 5Batch & Expiry Confirmed on Pack Boolean
Confirm batch number and expiry date on physical pack match the batch record — manual verification
- 6Pack Count Matches BOM Boolean
Confirm unit count per case matches the Bill of Materials specification
- 7Clean Room Temperature Text
Enter manufacturing environment temperature (°C) during production — GMP environmental monitoring
- 8Relative Humidity Text
Enter relative humidity (%) during production — required for GMP documentation of environmental conditions
- 9Differential Pressure Log File Upload
Upload differential pressure log for the manufacturing suite — confirms cleanroom integrity
- 10All Deviations Documented Boolean
Confirm any production deviations have been raised, investigated, and documented before release
- 11Regulatory Affairs Release Authorization Boolean
Regulatory Affairs confirms batch is cleared for distribution — final release gate with RA ID and timestamp
HAKIKI Features Used
See Hakiki in action
Build your first auditable workflow in minutes — no credit card required.
Get Started FreeMore in Heavy-Procedure Industries
Private Hospital
How to Run the WHO Surgical Safety Checklist Digitally — and Make It Count for Accreditation
Regional Airline
How to Run Pre-Flight Inspections With a Digital Audit Trail That Satisfies KCAA
FMCG Manufacturing Plant
How to Run In-Process Quality Control That Catches Defects Before They Become Batch Rejections