Guidelines for Developing a Stability Protocol as per ICH Q1A(R2)

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for preparing a stability protocol for drug substances and drug products in compliance with the ICH Q1A(R2) guidelines. This SOP ensures that the stability protocol is comprehensive, clear, and in line with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the preparation and review of stability protocols for drug substances and drug products intended for global markets.

3) Responsibilities

Stability Testing Team: Responsible for drafting the stability protocol in compliance with ICH Q1A(R2) guidelines.

Quality Assurance (QA) Team: Responsible for reviewing and approving the stability protocol.

Regulatory Affairs Team: Responsible for ensuring that the protocol meets regulatory expectations and is aligned with submission requirements.

4) Procedure

4.1 Initial Preparation

4.1.1 Obtain and review the latest version of the ICH Q1A(R2) guidelines.

4.1.2 Identify the drug substance or product and determine the type of stability study required (e.g., long-term, accelerated, or intermediate).

4.2 Components of the Stability Protocol

4.2.1 Include the following sections in the stability protocol:

• Objective and scope of the study
• Details of the drug substance or product, including batch number and manufacturing date
• Storage conditions and time points
• Tests to be conducted, including methods and acceptance criteria
• Responsibilities of the personnel involved
• Schedule for sampling, testing, and reporting

4.3 Approval and Finalization

4.3.1 Submit the draft protocol to the QA Team for review and approval.

4.3.2 Address any discrepancies or required changes identified by the QA Team and finalize the protocol for implementation.

5) Abbreviations, if any

ICH: International Council for Harmonisation
QA: Quality Assurance

6) Documents, if any

Draft stability protocol, approved stability protocol.

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products.

8) SOP Version

Version 1.0

Comprehensive Guide to Photostability and Oxidative Stability Studies in Pharmaceuticals

Introduction

Photostability and oxidative Stability Studies are essential components of a pharmaceutical product’s stability testing program. Both evaluate the robustness of drug substances and drug products under specific stress conditions — light and oxidative environments, respectively. These tests help determine potential degradation pathways and validate the protective capacity of the formulation and packaging. Regulatory bodies, including ICH, FDA, EMA, and WHO, expect robust data supporting these stress tests for product registration and market access.

Importance in Pharmaceutical Development

Understanding how light and oxidative stress impact drug integrity is critical in preventing therapeutic failure, adverse reactions, or stability-related recalls. These studies inform the selection of appropriate excipients, antioxidants, packaging systems, and storage conditions.

Photostability Testing Overview

Objective

To evaluate the effect of light exposure — both UV and visible — on a drug substance or finished product. This testing determines whether protective packaging is needed and validates label claims like “Protect from light.”

Guidance Source

• ICH Q1B: Photostability Testing of New Drug Substances and Products

Test Conditions

• UV light: 320–400 nm
• Visible light: 400–800 nm
• Total exposure: At least 1.2 million lux hours (visible) and 200 W•h/m² (UV)

Sample Setup

• Expose solid, liquid, or lyophilized forms in both open and closed containers
• Compare with a dark control (wrapped in aluminum foil)
• Test with/without primary packaging (e.g., blisters, bottles)

Assessment Parameters

• Color and appearance change
• Assay degradation using HPLC or UV-Vis
• Impurity profiling
• Photodegradation product identification

Oxidative Stability Testing Overview

Objective

To determine a product’s susceptibility to oxidation, a major degradation pathway for many APIs, especially those with unsaturated bonds, phenolic groups, or heteroatoms.

Common Stress Agents

• Hydrogen peroxide (H₂O₂): 0.1% to 3%
• AIBN (Azobisisobutyronitrile): for radical oxidation
• Atmospheric oxygen exposure
• Sodium hypochlorite (NaClO) – less common

Conditions

• Temperature: Room temperature or elevated (25°C to 40°C)
• Time: 1–7 days, depending on oxidation rate
• Sampling: At 0h, 4h, 24h, 48h, and 72h

Evaluated Parameters

• API degradation by HPLC
• Peroxide value (in oils, creams)
• Loss of antioxidant potency (e.g., ascorbic acid)
• Change in pH or color

Test Design Considerations

Photostability

• Use of validated light sources and chambers
• Calibrated lux meters and UV sensors
• Sample rotation during exposure for uniformity

Oxidative Testing

• Selection of oxidation strength relevant to the product class
• Replicates to confirm data reliability
• Control samples to ensure method specificity

Analytical Techniques

Photostability and oxidative studies must be supported by validated stability-indicating methods that can distinguish degradation products from the intact API.

• HPLC with PDA or MS detectors
• UV-Vis Spectroscopy for photolysis
• LC-MS for degradant identification
• Visual inspection and colorimetry

Packaging Evaluation

Photostability

• Amber vials vs clear vials comparison
• Foil blisters vs PVC/PVDC
• Carton vs no carton impact

Oxidative Stability

• Impact of oxygen-permeable packaging (e.g., low-density polyethylene)
• Use of oxygen scavengers or inert gas flushes

Regulatory Documentation

• CTD 3.2.P.8: Stability section must include photostability and oxidative data
• ICH Q1B report: Justification for light protection labeling
• ICH Q6A/B: Specifications for degradation product levels

Common Photodegradation Mechanisms

• Isomerization
• Photooxidation (with oxygen + light)
• Bond cleavage (e.g., N-O, C=C)
• Radical formation

Case Study: Antihypertensive Drug Photodegradation

A global pharma company conducted photostability tests on a photosensitive API under ICH Q1B Option 2 (UV and visible light). The exposed samples showed a 25% degradation in assay and yellowing of solution. Reformulating with amber glass packaging and adding EDTA as a chelating agent significantly improved resistance to photolysis. Regulatory approval included the label claim “Protect from light” and specified packaging requirements.

Challenges in Oxidative Stability Testing

• Overstressing leading to non-representative degradation
• Complex degradation profiles in polyphasic systems
• Low signal/noise ratio in early degradation detection

Solutions

• Pilot studies to determine optimal oxidant concentration
• Staggered sampling and duplicate analysis
• Use of mass balance techniques

Best Practices

• Follow ICH Q1B strictly and use calibrated photostability chambers
• Incorporate oxidative stress testing in method validation studies
• Use orthogonal methods for confirmation (HPLC + UV + MS)
• Integrate findings into packaging development early in formulation

Conclusion

Photostability and oxidative Stability Studies are crucial in ensuring pharmaceutical product integrity across storage, shipping, and usage conditions. Properly executed studies not only meet regulatory mandates but also preemptively mitigate risks of degradation, extending shelf life and safeguarding therapeutic performance. For expert-led SOPs, validation protocols, and compliance tools, refer to trusted insights at Stability Studies.

In-Depth Guide to Pharmaceutical Stability Testing Methods and Classifications

Introduction

Stability testing is a fundamental process in pharmaceutical development and manufacturing. It determines how the quality of a drug substance or product varies with time under the influence of environmental factors such as temperature, humidity, and light. These tests help establish a product’s shelf life, recommended storage conditions, and re-test periods, which are crucial for ensuring the drug’s efficacy and safety.

Understanding the different types of stability testing is essential not just for meeting regulatory standards set by the ICH, FDA, EMA, CDSCO, and WHO but also for internal quality assurance and supply chain decisions. This comprehensive guide explores each major type of stability testing, its methodology, applications, challenges, and compliance considerations.

What is Stability Testing?

Stability testing refers to the evaluation of a drug’s ability to retain its chemical, physical, microbiological, and therapeutic properties throughout its shelf life. These studies are conducted using well-defined protocols and under specific environmental conditions that mimic real-world scenarios.

Importance of Stability Testing

• Safety and Efficacy: Ensures the product remains effective and free from harmful degradation products.
• Regulatory Compliance: Mandatory for product approval and market release.
• Label Claims: Supports the establishment of expiration dates and storage conditions.
• Change Management: Validates the impact of changes in manufacturing, packaging, or formulation.

1. Real-Time Stability Testing

Real-time stability testing involves storing drug samples under recommended storage conditions for extended periods and evaluating them at pre-specified intervals. This is the most reliable method for determining actual shelf life.

Standard Conditions

• 25°C ± 2°C / 60% RH ± 5% RH for general products (Zone II)
• 30°C ± 2°C / 75% RH ± 5% RH for products in Zone IVb

Test Duration

Typically up to 24 or 36 months with analysis at 0, 3, 6, 9, 12, 18, and 24 months.

Applications

• Establishing official shelf life
• Filing data for NDAs, ANDAs, and global dossiers

2. Accelerated Stability Testing

Accelerated testing evaluates the drug’s stability at elevated temperature and humidity to predict its shelf life in a shorter timeframe.

Conditions

• 40°C ± 2°C / 75% RH ± 5% RH

Test Duration

Usually 6 months with analysis at 0, 1, 2, 3, and 6 months.

Benefits

• Early shelf-life estimation
• Helps in formulation screening and optimization

Limitations

Not suitable for products that degrade under stress but remain stable under normal conditions.

3. Intermediate Stability Testing

Intermediate testing is conducted at conditions between real-time and accelerated studies. It’s required when accelerated data shows significant changes.

Conditions

• 30°C ± 2°C / 65% RH ± 5% RH

Use Cases

• Validation of borderline stability profiles
• Supportive evidence for regulatory submissions

4. Stress Testing (Forced Degradation Studies)

Stress testing subjects the drug to extreme conditions to identify degradation pathways and to evaluate the intrinsic stability of the molecule.

Stress Conditions

• Thermal degradation (50–70°C)
• Hydrolysis (acidic and basic conditions)
• Oxidative stress (e.g., H₂O₂)
• Photolysis (light exposure)

Regulatory Relevance

Required to validate stability-indicating analytical methods and identify potential degradation products as per ICH Q1A and Q1B.

5. Photostability Testing

Per ICH Q1B, photostability testing evaluates the effects of light exposure on a drug substance or product.

Light Sources

• UV light (320–400 nm)
• Visible light (400–800 nm)

Parameters Assessed

• Color change
• Assay and degradation products
• Physical integrity

Implication

Outcomes guide the need for light-protective packaging like amber bottles or foil wraps.

6. Freeze-Thaw Stability Testing

This testing simulates the effects of repeated freezing and thawing, common during transportation or improper storage of biologics and injectables.

Cycles

• Typically 3–6 cycles between -20°C and 25°C

Evaluation Points

• Appearance
• pH
• Potency
• Sterility and endotoxin levels

7. In-Use Stability Testing

Performed on multidose products to determine stability during the usage period after opening.

Simulates

• Container opening and closing
• Dose withdrawal
• Environmental exposure

Key Products

• Eye drops
• Injectables
• Oral liquids

8. Microbiological Stability

This testing ensures that microbial growth is prevented throughout the product’s shelf life, particularly for preservative-containing formulations.

Tests Include

• Preservative Efficacy Testing (PET)
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)

Standards

• USP <51>
• Ph. Eur. 5.1.3

Special Designs: Bracketing and Matrixing

These are statistical designs that reduce the number of samples while still generating sufficient stability data.

Bracketing

Only the extremes (e.g., highest and lowest strengths) are tested.

Matrixing

Only a selected subset of all possible combinations of factors is tested at each time point.

Reference

ICH Q1D provides detailed guidance for these designs.

Stability Studies in Biologics

Stability Studies for biologics (mAbs, vaccines, peptides) are more complex due to their structural sensitivity.

• Aggregation and fragmentation studies
• Thermal ramp testing
• Excipient interaction studies

Stability Chamber Qualification

Stability chambers must be qualified to maintain uniform conditions for reliable data.

Qualification Includes

• IQ/OQ/PQ validation
• Temperature/humidity mapping
• 21 CFR Part 11 compliance for data integrity

Regulatory Guidelines

• ICH Q1A–F: Stability testing for new drug substances and products
• ICH Q5C: Stability of biotechnology products
• FDA CFR Title 21 Part 211: CGMP for finished pharmaceuticals

Case Study: Remediation Through Stability Data

A pharmaceutical company faced repeated product degradation failures in tropical markets. Accelerated stability testing under 40°C/75% RH revealed that the plastic bottle used had high moisture permeability. By switching to aluminum blisters and adding desiccants, the product passed all criteria and received WHO PQ certification.

Best Practices

• Follow ICH guidelines rigorously
• Use validated, stability-indicating methods
• Incorporate change control procedures
• Ensure continuous chamber monitoring and alerts

Conclusion

Pharmaceutical stability testing is a multidimensional discipline vital to drug safety, efficacy, and regulatory approval. Each type of stability study provides unique insights into the product’s behavior and potential failure modes. By applying ICH-recommended practices and adapting strategies for different drug categories, companies can mitigate risk, extend shelf life, and ensure patient trust. For more comprehensive guidance on designing compliant protocols and aligning with current global trends, explore additional resources at Stability Studies.

Standard Operating Procedure for Stability Testing According to PMDA Guidelines

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies in compliance with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) guidelines to ensure the safety, quality, and efficacy of drug products.

2) Scope

This SOP applies to all drug products requiring stability testing as per PMDA guidelines. It is relevant to departments involved in production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing according to PMDA guidelines.
• Quality Assurance (QA) Team: Reviews and approves stability protocols and reports to ensure compliance with PMDA standards.
• Regulatory Affairs Team: Ensures stability data is prepared in accordance with PMDA submission requirements.

4) Procedure

1. Preparation of Stability Protocol
   1. Develop a stability study protocol in alignment with PMDA guidelines, specifying storage conditions, test intervals, and analytical methods.
   2. Submit the protocol for review and approval to the QA team.
2. Execution of Stability Studies
   1. Store samples in stability chambers under specified conditions (e.g., 25°C/60% RH, 30°C/75% RH) as per PMDA requirements.
   2. Conduct tests at defined intervals to evaluate stability parameters such as potency, degradation products, and dissolution.
   3. Document all test results, observations, and any deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze stability data to ensure compliance with PMDA standards.
   2. Prepare a stability study report for submission to the PMDA, detailing all findings, conclusions, and recommendations.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• PMDA: Pharmaceuticals and Medical Devices Agency
• RH: Relative Humidity

6) Documents, if any

• Stability Study Protocol
• Analytical Test Reports
• Stability Study Report

7) Reference, if any

• PMDA Guidelines on Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0

Standard Operating Procedure for Stability Testing Following Post-Approval Changes

1) Purpose

The purpose of this SOP is to provide a standardized approach for managing stability testing following post-approval changes to drug substances and products in compliance with US FDA guidelines.

This SOP applies to all stability studies required following post-approval changes, such as formulation, manufacturing process, packaging, or storage conditions, for drug substances and products. It is relevant to departments involved in quality control, quality assurance, regulatory affairs, and production.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing as per the revised protocol.
• Quality Assurance (QA) Team: Reviews and approves protocols and stability study results following post-approval changes.
• Regulatory Affairs Team: Ensures all stability data related to post-approval changes comply with US FDA requirements.

4) Procedure

1. Development of Revised Stability Protocol
   1. Draft a revised stability study protocol to account for the post-approval changes, detailing storage conditions, test intervals, and analytical methods.
   2. Submit the revised protocol for review and approval by the QA team.
2. Execution of Stability Studies
   1. Store samples under conditions specified in the revised protocol.
   2. Conduct analytical tests at each interval to assess the impact of post-approval changes on stability parameters.
   3. Document all test results, observations, and deviations from the revised protocol.
3. Data Analysis and Reporting
   1. Analyze stability data to ensure compliance with FDA requirements following post-approval changes.
   2. Prepare a comprehensive stability study report for submission to the FDA, detailing the impact of post-approval changes.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• FDA: Food and Drug Administration

6) Documents, if any

• Revised Stability Study Protocol
• Analytical Test Reports
• Stability Study Report for Post-Approval Changes

7) Reference, if any

• FDA Guidance for Industry: Changes to an Approved NDA or ANDA

8) SOP Version

Version 1.0

Why photostability testing is important:

Many pharmaceutical products are susceptible to light-induced degradation, which can lead to reduced potency, the formation of harmful impurities, or changes in physical appearance. Photostability testing identifies these risks early.

This allows manufacturers to define appropriate packaging and labeling that protect the product and extend shelf life.

ICH Q1B sets the global benchmark:

The ICH Q1B guideline provides a standardized approach for evaluating photostability. It outlines the minimum light exposure, equipment requirements, and evaluation criteria needed to simulate light-induced stress under controlled conditions.

Adhering to this guideline ensures globally accepted results that support product registration and commercialization.

Implications for formulation and packaging:

Photostability results influence choices around primary packaging materials—especially whether amber, opaque, or foil-lined containers are needed. They also inform the selection of excipients that may stabilize or worsen light sensitivity.

This tip ensures the data you generate not only meets regulatory demands but actively contributes to smarter formulation development.

Regulatory and Technical Context:

Core principles of ICH Q1B:

ICH Q1B requires that drug substances and products be exposed to a combination of visible and ultraviolet (UV) light equivalent to at least 1.2 million lux hours and 200 watt-hours/square meter.

This ensures that photostability testing simulates extended daylight exposure and meets regulatory thresholds for evaluating light sensitivity.

Types of light sources used:

Validated light sources may include xenon arc, fluorescent lamps, or a combination of UV and cool white fluorescent tubes. These sources must be calibrated and traceable to ensure consistent output.

Chambers or enclosures used for photostability must be temperature-controlled and regularly qualified to comply with ICH standards.

Documentation for regulatory submission:

Results from photostability studies are required in Module 3 of the Common Technical Document (CTD). This includes details on test conditions, results, analytical methods, and any packaging adaptations made as a result.

Demonstrating adherence to ICH Q1B enhances regulatory trust in the product’s long-term quality profile.

Best Practices and Implementation:

Set up validated light exposure conditions:

Use light sources that emit the required spectrum and intensity. Conduct regular qualification and calibration of lamps, sensors, and enclosures to maintain compliance.

Include temperature and humidity monitoring to prevent confounding effects from heat or moisture during testing.

Design the study to include key variables:

Test both the drug substance and drug product in their primary packaging. Evaluate uncovered and wrapped samples to determine if the packaging protects the product from light exposure.

Use validated stability-indicating analytical methods to detect degradation products specific to photolytic breakdown.

Translate findings into design improvements:

If photodegradation is observed, implement protective measures such as UV-blocking containers, foil blisters, or secondary packaging. Also consider reformulation if excipients contribute to photosensitivity.

Update product labeling to include storage precautions like “Protect from light” when justified by study outcomes.

Standard Operating Procedure for Stability Testing of New Dosage Forms as per ICH Q1C

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability testing of new dosage forms in compliance with ICH Q1C guidelines to ensure their quality, safety, and efficacy over their intended shelf life.

2) Scope

This SOP applies to all new dosage forms that require stability testing under ICH Q1C guidelines. It is relevant to departments involved in production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing in compliance with ICH Q1C guidelines.
• Quality Assurance (QA) Team: Reviews and approves stability protocols and reports.
• Regulatory Affairs Team: Ensures stability data meets submission requirements.

4) Procedure

1. Preparation of Stability Protocol
   1. Draft a stability study protocol for the new dosage form, specifying storage conditions, test intervals, and analytical methods.
   2. Ensure the protocol complies with ICH Q1C guidelines.
   3. Submit the protocol for review and approval by the QA team.
2. Execution of Stability Studies
   1. Store samples in stability chambers under specified conditions.
   2. Conduct tests at defined intervals to assess stability parameters specific to the new dosage form.
   3. Document all test results, observations, and any deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze data to ensure compliance with ICH Q1C requirements.
   2. Prepare a comprehensive stability study report for submission to the regulatory authorities.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• ICH: International Council for Harmonisation

6) Documents, if any

• Stability Study Protocol
• Analytical Test Reports
• Stability Study Report

7) Reference, if any

• ICH Q1C: Stability Testing of New Dosage Forms

8) SOP Version

Version 1.0

Standard Operating Procedure for Preparing Stability Reports for ANDAs

1) Purpose

The purpose of this SOP is to provide a standardized procedure for developing stability study reports for Abbreviated New Drug Applications (ANDAs) to the US FDA, ensuring compliance with regulatory requirements.

2) Scope

This SOP applies to all stability studies conducted in support of ANDA submissions. It is relevant to departments involved in regulatory affairs, quality control, and quality assurance.

3) Responsibilities

• Regulatory Affairs Team: Compiles and submits stability study reports for ANDA submissions.
• Quality Assurance (QA) Team: Reviews and approves stability study reports.
• Quality Control (QC) Team: Provides validated stability data for inclusion in reports.

4) Procedure

1. Data Compilation
   1. Gather all stability data, including test results, storage conditions, and time points.
   2. Ensure data complies with FDA requirements for ANDA submissions.
2. Report Preparation
   1. Prepare stability study reports, including all relevant data, analyses, and interpretations.
   2. Format the report according to FDA guidelines for ANDA submissions.
3. Submission Preparation
   1. Compile the stability documentation as part of the ANDA package.
   2. Submit the package to the Regulatory Affairs team for final review and submission to the FDA.

5) Abbreviations, if any

• ANDA: Abbreviated New Drug Application
• QC: Quality Control
• QA: Quality Assurance
• FDA: Food and Drug Administration

6) Documents, if any

• Stability Data Package
• Stability Report for ANDA Submission

7) Reference, if any

• FDA Guidance for Industry: ANDA Submissions – Stability Testing of Drug Substances and Products

8) SOP Version

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Standard Operating Procedure for Stability Study Documentation for NDAs

1) Purpose

The purpose of this SOP is to provide a standardized procedure for documenting stability studies in support of New Drug Applications (NDAs) to the US FDA to ensure compliance with regulatory requirements.

2) Scope

This SOP applies to all stability studies conducted in support of NDAs to the US FDA. It is relevant to departments involved in regulatory affairs, quality control, and quality assurance.

3) Responsibilities

• Regulatory Affairs Team: Prepares stability study documentation for NDA submission.
• Quality Assurance (QA) Team: Reviews and approves stability study documentation.
• Quality Control (QC) Team: Provides validated data for NDA submissions.

4) Procedure

1. Data Compilation
   1. Gather all stability data, including test results, storage conditions, and time points.
   2. Ensure data is validated and compliant with FDA guidelines.
2. Document Formatting
   1. Format stability data according to FDA requirements, including summaries, tables, and graphs.
   2. Prepare a comprehensive stability report, including all relevant data, analyses, and interpretations.
3. Submission Preparation
   1. Compile the stability documentation as part of the NDA package.
   2. Submit the NDA package to the Regulatory Affairs team for final review and submission to the FDA.

5) Abbreviations, if any

• NDA: New Drug Application
• QC: Quality Control
• QA: Quality Assurance
• FDA: Food and Drug Administration

6) Documents, if any

• Stability Data Package
• Stability Report for NDA Submission

7) Reference, if any

• FDA Guidance for Industry: Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0

Standard Operating Procedure for Stability Testing of Modified Release Products

1) Purpose

The purpose of this SOP is to provide a standardized approach for conducting stability studies for modified-release products in compliance with US FDA and ICH guidelines to ensure their safety, quality, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all modified-release products that require stability testing under FDA and ICH guidelines. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing as per protocol.
• Quality Assurance (QA) Team: Reviews and approves stability protocols and reports.
• Regulatory Affairs Team: Ensures stability data meets submission requirements.

4) Procedure

1. Preparation of Stability Protocol
   1. Draft a stability study protocol detailing storage conditions, test intervals, and analytical methods.
   2. Ensure the protocol is compliant with FDA and ICH guidelines.
   3. Submit the protocol for review and approval by the QA team.
2. Execution of Stability Studies
   1. Store samples in designated chambers under specified conditions (e.g., 25°C/60% RH, 30°C/65% RH).
   2. Conduct tests at each interval to assess stability parameters specific to modified-release formulations, such as dissolution and drug release profiles.
   3. Document all observations, test results, and any deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze data to ensure compliance with FDA and ICH guidelines for modified-release products.
   2. Prepare a comprehensive stability study report for submission.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• ICH: International Council for Harmonisation
• FDA: Food and Drug Administration
• RH: Relative Humidity

6) Documents, if any

• Stability Study Protocol
• Analytical Test Reports
• Stability Study Report

7) Reference, if any

• FDA Guidance for Industry: Extended Release and Long-Acting Products
• ICH Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0