# Stability Protocol

> Use this template to iCH stability protocol for [product_name] batches.

## 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] |

## Objective

State the stability objective, product, dosage form, strength, and intended filing or monitoring use.

| 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.]

## Study Design

Identify batches, packaging configurations, batch size, manufacturing dates, and study type.

| 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.]

## Storage Conditions

List long-term, intermediate, accelerated, and special conditions with temperature and humidity ranges.

| 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.]

## Testing Schedule

Define pull points, sample quantities, test panels, and retain 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.]

## Analytical Methods

List method numbers, validation status, laboratories, and sample handling expectations.

| 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.]

## Acceptance Criteria

Define specifications for assay, impurities, dissolution, appearance, moisture, and microbiology where applicable.

| 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.]

## Pull and Reporting Controls

Describe chamber monitoring, missed pulls, OOS/OOT handling, data review, and report approval. Use concise regulatory language and tables for conditions and time points.

| 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] |