SOP for Preparing Stability Study Reports – V 2.0

Procedure for Preparing Stability Study Reports

Department	Quality Assurance (QA)/Quality Control (QC)/Research & Development (R&D)
SOP No.	SOP/Ointment/156
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for preparing Stability Study Reports in pharmaceutical manufacturing. Stability studies evaluate the effect of environmental factors such as temperature, humidity, and light on drug products to determine their shelf life and storage conditions.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Research & Development (R&D) departments responsible for conducting stability studies, analyzing data, and preparing Stability Study Reports for regulatory compliance.

3. Responsibilities

QC Analyst: Conducts stability tests and records analytical data.
QA Officer: Reviews stability study reports for compliance.
R&D Scientist: Designs and monitors stability studies.
QA Manager: Approves final Stability Study Reports.

4. Accountability

The QA and R&D Managers are accountable for ensuring that Stability Study Reports comply with GMP, ICH, WHO, and FDA guidelines.

5. Procedure

5.1 Types of Stability Studies

Stability studies are classified into the following categories:

Accelerated Stability Studies: Conducted at elevated temperature and humidity conditions to predict long-term stability.
Long-Term Stability Studies: Conducted under normal storage conditions to determine

real-time stability.

Intermediate Stability Studies: Performed at conditions between long-term and accelerated studies.

Photostability Studies: Evaluates the effect of light exposure on drug products.

5.2 Stability Study Protocol Development

A Stability Study Protocol must be prepared before initiating stability testing.
The protocol must include:
- Purpose and scope of the study.
- Batch details (Batch No., manufacturing and expiry date).
- Storage conditions and test intervals.
- Test parameters (e.g., assay, pH, viscosity, microbial limits).
- Acceptance criteria and test methods.
The Stability Study Protocol must be reviewed and approved by the QA Manager.

5.3 Sample Preparation and Storage

Stability samples must be collected from representative batches.
Samples must be labeled with:
- Product name and batch number.
- Storage condition and test interval.
- Date of sample collection.
Samples must be stored in **stability chambers** under defined conditions:
Storage conditions:
- Accelerated: **40°C ± 2°C / 75% RH ± 5% RH**
- Long-Term: **25°C ± 2°C / 60% RH ± 5% RH**
- Intermediate: **30°C ± 2°C / 65% RH ± 5% RH**
- Photostability: **Light exposure per ICH guidelines**

5.4 Stability Testing and Data Recording

QC must conduct tests at predefined intervals (e.g., 1 month, 3 months, 6 months, 12 months, 24 months).
Tests include:
- Physical tests (appearance, odor, color).
- Chemical tests (assay, pH, degradation products).
- Microbiological tests (total viable count, endotoxin levels).
All test results must be recorded in the **Stability Testing Log.**

5.5 Preparation of Stability Study Reports

The Stability Study Report must include:
- Summary of stability testing results.
- Trend analysis of critical parameters.
- Degradation profile and extrapolated shelf life.
- Recommendations on storage conditions and expiry period.
The report must be reviewed by the **QA Manager** before submission.

5.6 Review and Approval of Stability Study Reports

QA must review stability data monthly.
Regulatory compliance must be ensured before final approval.
Reports must be archived for **a minimum of 5 years.**

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
R&D – Research & Development
RH – Relative Humidity
ICH – International Council for Harmonisation

7. Documents

Stability Study Protocol Template (Annexure-1)
Stability Study Report Template (Annexure-2)

8. References

ICH Q1A – Stability Testing of New Drug Substances
WHO Guidelines on Stability Studies
US FDA Guidance on Stability Testing

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Stability Study Protocol Template

Product Name	Batch No.	Storage Condition	Test Interval	QA Approval
Ointment A	12345	40°C/75% RH	0, 1, 3, 6, 12 months	Approved

Annexure-2: Stability Study Report Template

Date	Test Parameter	Initial Value	6-Month Value	12-Month Value	QA Review
02/02/2025	Assay	99.8%	99.5%	98.9%	Reviewed

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Procedure	Improved Documentation	QA Head