# Change Control Request

> Use this template to controlled assessment for proposed GMP change to [system_or_process].

## Template Metadata

| Field | Details |
|-------|---------|
| Category | Pharma & Biotech |
| Owner | [Team or owner] |
| Version | [Version number] |
| Effective Date | [Date] |
| Review Cycle | [Monthly / Quarterly / Annual / Event-based] |
| Status | [Draft / In Review / Approved] |

## Change Summary

Describe the proposed change, change type, affected product or system, and requested effective date.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Rationale

Explain why the change is needed and expected benefit.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Impacted Areas

Assess documents, equipment, computerized systems, materials, methods, training, suppliers, and batches.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Risk Assessment

Document quality, patient safety, validation, data integrity, and supply risks with mitigations.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Implementation Plan

List tasks, owners, dependencies, target dates, and rollback approach.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Validation Needs

State qualification, process validation, cleaning validation, or analytical validation requirements.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Regulatory Assessment

Identify filing, notification, annual report, or no-report rationale by market. Use precise controlled-change language with tables for impacts and implementation tasks.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Review and Signoff

Document review conclusions, approvals, unresolved items, and next review date.

| Role | Name | Date | Notes |
|------|------|------|-------|
| Preparer | [Name] | [Date] | [Notes] |
| Reviewer | [Name] | [Date] | [Notes] |
| Approver | [Name] | [Date] | [Notes] |