Change control is how a pharmaceutical quality system stays in a validated state while processes, equipment, documents and suppliers change. The commonest gaps are changes implemented before approval, impact assessments that miss training or validation, and changes never checked for effectiveness.
What the template covers
- Change request — current and proposed state, reason, permanent or temporary.
- Impact assessment across nine areas, each with an action and owner.
- Risk assessment of making — and not making — the change.
- Approval before implementation.
- Implementation actions, verification and effectiveness review.
- Closure.
Tips
- Assess computerised systems explicitly — configuration changes need validation impact too.
- Check regulatory filings early; some changes need prior approval.
- Name the first batches made after the change and review them.