the specified formulation guidelines.

Laboratory Technicians: Conduct the stability studies, monitor storage conditions, and record stability data including physical appearance, API content, pH, and dissolution profiles.

Quality Control (QC): Ensure that all stability studies comply with regulatory standards and that the results are documented accurately. QC also verifies that formulations meet the required specifications.

Project Managers: Coordinate the stability study process, ensure resources are available, and ensure timely completion of stability studies according to the study timeline.

4) Procedure

The following steps outline the procedure for conducting pilot stability studies of formulations:

1. Step 1: Define Stability Study Requirements
   1. Identify the formulation to be tested and define the stability parameters to be assessed (e.g., potency, appearance, pH, dissolution, microbial quality).
   2. Define the appropriate storage conditions based on the formulation’s characteristics, including temperature (e.g., room temperature, refrigerated, accelerated conditions), humidity, and light exposure.
   3. Determine the time points for sampling (e.g., 0, 3, 6, 12 months) and the frequency of stability data collection.
2. Step 2: Prepare Formulation Samples
   1. Prepare the formulation batches according to the intended scale, ensuring that the batch sizes are consistent and representative of the formulation to be tested in the pilot stability study.
   2. Package the formulations in suitable containers (e.g., bottles, blisters) that represent typical packaging for commercial use, ensuring that the packaging materials are compatible with the formulation and storage conditions.
   3. Label each sample with the batch number, formulation type, and storage conditions for easy tracking.
3. Step 3: Store the Formulations under Defined Conditions
   1. Store the formulation samples in designated stability chambers or storage units that can maintain the required temperature and humidity conditions for the duration of the study.
   2. Monitor and record environmental conditions, including temperature, humidity, and light exposure, using environmental monitoring equipment such as data loggers.
   3. Ensure that temperature-controlled storage units are calibrated and regularly checked to confirm they maintain the required conditions.
4. Step 4: Conduct Stability Testing at Defined Time Points
   1. At each time point (e.g., 0, 3, 6, 12 months), retrieve the samples from storage and assess the following stability parameters:
      • Physical appearance (e.g., color, texture, clarity, phase separation)
      • Chemical integrity (e.g., potency, degradation products)
      • pH and other chemical properties (if applicable)
      • Dissolution or drug release rate (if applicable)
      • Microbial testing (if applicable)
   2. Perform all tests using validated analytical methods (e.g., HPLC, UV-Vis spectroscopy, dissolution testing) to quantify the drug content and evaluate its stability.
5. Step 5: Analyze Stability Data
   1. Compare the results from each time point to baseline (0-month) data to assess the formulation’s stability over time. Analyze data for trends, such as changes in potency, pH, appearance, and dissolution rates.
   2. Assess the impact of storage conditions on the formulation’s quality attributes and determine whether the formulation remains within acceptable limits (e.g., ±5% of labeled drug content).
   3. If significant degradation or changes are observed, investigate the potential causes (e.g., temperature fluctuations, packaging failure) and evaluate the need for formulation adjustments.
6. Step 6: Draw Conclusions and Report Findings
   1. Summarize the stability results, including any changes observed at different time points and conclusions regarding the formulation’s stability under the specified storage conditions.
   2. Prepare a report that includes raw data, analysis, and recommendations for storage conditions, packaging, and potential adjustments to the formulation or study design.
   3. Provide recommendations for long-term storage conditions and any additional stability studies that may be needed before large-scale production or regulatory submission.
7. Step 7: Documentation and Reporting
   1. Ensure that all stability study activities are documented in compliance with Good Laboratory Practices (GLP) and regulatory requirements.
   2. Prepare detailed records of the study, including formulation preparation, stability test results, data analysis, and recommendations for storage conditions and formulation adjustments.
   3. Ensure that all records are signed, dated, and properly archived for future reference.
8. Step 8: Sample Disposal
   1. Dispose of any remaining test samples, solvents, and materials according to safety protocols and environmental regulations.
   2. Ensure that hazardous materials are disposed of in designated chemical waste containers in compliance with safety guidelines.

5) Documents

The following documents should be maintained during the pilot stability study of formulations:

1. Formulation Preparation Records
2. Stability Study Protocol
3. Environmental Monitoring Records
4. Stability Testing Reports
5. Raw Data and Observations
6. Stability Study Summary Report
7. Sample Disposal Records

6) Abbreviations

• API: Active Pharmaceutical Ingredient
• GLP: Good Laboratory Practices
• HPLC: High-Performance Liquid Chromatography
• RH: Relative Humidity
• USP: United States Pharmacopeia

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• FDA Guidance for Stability Testing of Drug Products
• USP <1079> on Stability Testing
• ICH Q1A(R2) Stability Testing of New Drug Substances and Products

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Pilot Stability Study Results Template

Formulation ID	Storage Conditions	Time Point	Physical Appearance	Potency (%)	pH	Release Profile	Remarks