A change control SOP you can start from today
A short, editable procedure written for teams that manage changes in an electronic quality management system. Every step is mandatory, nothing is decoration, and the boxes marked 'Why this matters' explain the reason behind each rule.
What is inside
- Purpose, scope and out of scope, with the definitions an inspector expects
- A RACI table for who raises, classifies, assesses, approves and verifies
- Minimum eQMS requirements: audit trail, e-signatures, workflow that blocks unapproved work
- Three-class classification (minor, major, critical) with approvers per class
- A nine-area impact assessment: regulatory, quality, validation, documents, training, suppliers, systems, stock, resources
- Approval before implementation, emergency changes, closure and effectiveness check
- Plain-language 'Why this matters' boxes so the reasoning survives the next audit
How to use it
Treat it as a starter, not a finished document. Complete the text in square brackets (company name, timelines, approvers), check the cross-references against your own SOP numbering, and have your Quality Unit approve it before use. The intervals are recommended defaults and your site sets the final value. If your products, licences or outsourcing set-up need more, the process behind each step is explained in the complete guide to GMP change control.
Want to test the procedure you end up with? Run it against the change control checklist or the ten-question self-check.