Tablets: SOP for Documentation of Stability Study Results – V 2.0

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Tablets: SOP for Documentation of Stability Study Results – V 2.0

Standard Operating Procedure for Documentation of Stability Study Results

Department Tablet
SOP No. SOP/TAB/206/2025
Supersedes SOP/TAB/206/2022
Page No. Page 1 of 7
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

This SOP defines the procedure for documenting stability study results in the tablet department. It ensures that stability data is accurately recorded, organized, and maintained to meet regulatory requirements and internal standards.

2. Scope

This SOP applies to all stability studies conducted on tablet products, including raw materials, in-process materials, and finished products. It covers the documentation process from the initial stability testing to the final results report.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for conducting stability testing and maintaining accurate records of all stability study results.
  • Quality Assurance (QA) Team: Responsible for ensuring that stability study results are documented according to regulatory guidelines and internal procedures. QA ensures proper data review, approval, and archiving.
  • Regulatory Affairs: Ensures compliance with applicable regulatory guidelines related to stability studies, including ICH guidelines.
  • Production Team: Ensures that stability samples are stored in the appropriate conditions as outlined in the stability protocol.

4. Accountability

The QA Manager is accountable for overseeing the documentation of stability study results. The QC Team is responsible for conducting stability tests and ensuring all data is accurately recorded.

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5. Procedure

5.1 Stability Study Design

  1. Design the stability study protocol based on the product type and regulatory requirements (e.g., ICH Q1A, Q1B, USP guidelines).
  2. Define the study parameters, such as temperature, humidity, and light conditions, and establish the time points for sampling and testing.
  3. Document the stability study protocol and obtain approval from the QA team before starting the study (Annexure-1).

5.2 Sample Preparation

  1. Select representative samples of the batch or product to be included in the stability study, ensuring that the samples reflect typical manufacturing conditions.
  2. Prepare and label stability samples with batch number, sampling date, and any other relevant information as per the stability study protocol.
  3. Store the samples in the designated stability storage conditions (e.g., stability chambers) according to the protocol (Annexure-2).

5.3 Testing and Data Collection

  1. Conduct the stability tests according to the approved protocol, ensuring that each test is performed at the specified time points (e.g., 0, 3, 6, 12 months).
  2. Common tests may include dissolution, assay, hardness, moisture content, and microbiological testing, depending on the product requirements.
  3. Document all test results promptly and accurately in the stability study results log (Annexure-3). Ensure that each test result is reviewed and verified by the responsible QC analyst.

5.4 Review of Stability Data

  1. The QA team will review the stability study results to ensure that all data is complete, accurate, and conforms to regulatory and internal standards.
  2. Evaluate the stability of the product by comparing the results at each time point with the acceptance criteria defined in the stability protocol (Annexure-4).
  3. If any results are outside the acceptable range, investigate the cause of the deviation and take appropriate corrective actions.
  4. Document the review process and approve the final stability study results in the stability report (Annexure-5).
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5.5 Reporting of Stability Study Results

  1. Compile the final stability report, summarizing all findings, including test results, conclusions, and any deviations or corrective actions taken (Annexure-6).
  2. Include a summary of the shelf life, recommended storage conditions, and expiration date based on the stability data.
  3. Submit the final stability report for QA review and approval.

5.6 Archiving of Stability Data

  1. Once the stability study is completed, archive all related documents, including raw data, test results, protocols, and reports, for the required retention period.
  2. Ensure that all stability study documentation is securely stored in a centralized location for easy access and retrieval during audits or inspections (Annexure-7).

5.7 Monitoring and Review of Ongoing Stability Studies

  1. Conduct periodic reviews of ongoing stability studies to ensure that they are progressing according to the plan and in compliance with regulatory requirements.
  2. Update the stability study documentation as necessary if there are any changes in regulatory guidelines or product formulations.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • ICH: International Council for Harmonisation
  • USP: United States Pharmacopeia
  • RSD: Relative Standard Deviation

7. Documents

  1. Stability Study Protocol (Annexure-1)
  2. Stability Study Results Log (Annexure-3)
  3. Stability Study Report (Annexure-5)
  4. Final Stability Study Summary (Annexure-6)
  5. Stability Study Data Archive (Annexure-7)
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8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • ICH Q1A – Stability Testing of New Drug Substances and Products
  • USP <1225> – Validation of Analytical Methods

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

Batch Number Storage Conditions Time Points Tests Conducted
Batch-12345 25°C ± 2°C, 60% ± 5% RH 0, 3, 6, 12 months Assay, Dissolution, Moisture Content

Annexure-2: Stability Sample Storage Conditions

Batch Number Storage Location Storage Conditions Sample ID
Batch-12345 Stability Chamber A 25°C ± 2°C, 60% ± 5% RH Sample-01

Annexure-3: Stability Study Results Log

Sample ID Test Date Test Parameter Result
Sample-123 01/03/2026 Assay 99.5%

Annexure-4: Stability Study Acceptance Criteria

Test Parameter Acceptance Criteria
Assay 98% – 102%

Annexure-5: Stability Study Report

Batch Number Final Test Results Conclusions
Batch-12345 Pass Product stable for 12 months at 25°C and 60% RH

Annexure-6: Stability Study Data Archive

Document File Location Retention Period
Stability Study Report Document Archive A 5 years

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated stability study process Added new testing parameters QA Head
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