Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Stability Studies of Finished Goods. This SOP ensures the proper evaluation of finished goods over time under various environmental conditions to assess their quality, efficacy, and safety.

1. Purpose

The purpose of this SOP is to define the procedure for conducting stability studies on finished goods to assess the impact of various environmental factors on their quality, shelf life, and performance. Stability studies help ensure that finished products maintain their intended quality, safety, and efficacy over their defined shelf life.

2. Scope

This SOP applies to all finished goods manufactured by [Company Name], including but not limited to:

• Pharmaceutical products (tablets, capsules, injectables)

• Biologics

• Nutraceuticals

• Cosmetics

• Food products

The study covers evaluation under different environmental conditions such as temperature, humidity, and light exposure.

3. Responsibilities

• Quality Control (QC) Personnel:

  • Conduct stability testing as per this SOP.

  • Ensure proper storage and handling of samples.

  • Record and report stability data accurately.

• Quality Assurance (QA) Department:

  • Oversee the stability study protocol and ensure regulatory compliance.

  • Review and approve stability study reports.

• Regulatory Affairs (RA):

  • Ensure that stability studies comply with local and international regulatory requirements.

• Manufacturing Team:

  • Provide samples of finished goods for stability studies.

4. Definitions

• Stability Study: The process of testing a product over time under controlled conditions to evaluate how it maintains its quality.

• Accelerated Stability Testing: Conducted at higher-than-normal temperatures and humidity levels to predict the product’s shelf life.

• Real-Time Stability Testing: Conducted at the product’s intended storage conditions to monitor product stability throughout its shelf life.

5. Materials and Equipment Required

• Finished goods samples (at various stages of production)

• Stability chambers (temperature and humidity-controlled)

• Stability study data recording forms

• Analytical instruments (e.g., HPLC, UV-Vis, pH meter)

• Labels for identification and tracking

• Stability study protocols and guidelines

• PPE (Personal Protective Equipment)

6. Procedure

6.1 Preparation for Stability Study

1. Review of Product Specifications:

   • Review the finished goods specifications for parameters to be tested (e.g., physical appearance, pH, potency, dissolution, microbial content).

2. Sampling Plan:

   • Randomly select a representative batch of finished goods (based on batch size).

   • Ensure samples are taken according to approved sampling plans.

   • Each sample should be properly labeled with batch number, date of sampling, and other relevant identifiers.

3. Storage Conditions:

   • Stability studies should be conducted under recommended storage conditions.

   • For accelerated stability, use higher-than-normal temperature and humidity conditions, as defined by the regulatory guidelines.

   • For real-time studies, store the products at the temperature and humidity conditions specified on the product label.

6.2 Types of Stability Studies

• Accelerated Stability Testing:

  • Conduct accelerated stability studies at elevated temperatures (e.g., 40°C ± 2°C) and high humidity (e.g., 75% RH).

  • Test the product at time intervals (e.g., 0, 3, 6, 9, 12 months) to predict the product’s stability under real-time conditions.

• Real-Time Stability Testing:

  • Store samples under the actual recommended storage conditions (e.g., 25°C ± 2°C and 60% RH).

  • Test the product at pre-determined time intervals (e.g., 0, 3, 6, 9, 12, 18, 24 months) to assess changes over the shelf life.

6.3 Testing Parameters

• The following parameters should be tested regularly during the stability study:

  • Appearance: Color, texture, odor, and physical form

  • Organoleptic Properties: Taste, odor (especially for oral formulations)

  • pH: For liquids and semi-solids

  • Potency/Active Ingredient Assay: To ensure the product contains the required active ingredient

  • Microbial Content: For microbiological stability

  • Dissolution Rate: For oral solid dosage forms (e.g., tablets, capsules)

  • Packaging Integrity: Condition of the packaging and labeling

  • Packaging Materials: Any degradation or changes in the materials used (e.g., blister packs, bottles)

6.4 Sampling Time Points

• Samples should be tested at regular intervals, typically:

  • 0 months (initial testing at the start of the study)

  • 3 months

  • 6 months

  • 9 months

  • 12 months

  • Every 6 months thereafter (up to 24 months or as required)

• In case of accelerated stability studies, test at 3, 6, 9, and 12 months intervals.

6.5 Data Recording and Evaluation

• Record all data in the Stability Study Log.

• Evaluate the following:

  • Stability of active ingredients

  • Changes in physical properties (appearance, dissolution, etc.)

  • Deviation from specifications

• Report Results:

  • After completion of the study, prepare a Stability Report including:

    • Results from testing at various time points

    • Comparison of results with initial specifications

    • Assessment of product stability, including predicted shelf life

6.6 Reporting and Review

• All data from the stability study should be compiled and reviewed by the QA team.

• Final Stability Report should be approved by QA and filed for future reference.

7. Documentation and Record Keeping

• Maintain stability study records for each product batch.

• Include:

  • Stability study protocol

  • Raw data from testing

  • Stability study logbook

  • Final report and conclusions

• Store records in the QA archive for the required retention period.

8. Compliance and Regulatory Considerations

• Ensure compliance with applicable local and international regulations (e.g., ICH Guidelines, FDA, EMA, WHO) for stability testing.

• Perform periodic reviews of stability data to confirm shelf life extension or to make regulatory submissions as necessary.

9. Precautions

• Ensure stability chambers are calibrated and regularly maintained.

• Avoid contamination of samples during handling and testing.

• Follow Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) at all times.

10. References

• International Council for Harmonization (ICH) Stability Guidelines

• WHO Guidelines on Stability Testing

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