SOP for Stability Testing of Lyophilized Products

Standard Operating Procedure for Stability Testing of Lyophilized Products

1) Purpose

This SOP outlines the procedure for conducting stability testing on lyophilized products to ensure their long-term viability, potency, and safety throughout the product’s shelf life.

2) Scope

This SOP applies to all personnel responsible for conducting stability testing of lyophilized products, including formulation scientists, laboratory technicians, and QA personnel.

3) Responsibilities

Formulation Scientists: Responsible for developing the stability testing protocol and ensuring that the testing parameters reflect the product’s storage conditions and intended use.
Laboratory Technicians: Responsible for conducting stability testing at designated time points and accurately recording the results.
QA Personnel: Responsible for reviewing and verifying the stability testing data.

4) Procedure

4.1 Stability Testing Protocol

4.1.1 Selection of Testing Conditions

4.1.1.1 Select stability testing conditions that reflect real-time and accelerated aging conditions, such as storage at 2-8°C, room temperature, and elevated temperatures (e.g., 40°C).

4.1.2 Testing Schedule

4.1.2.1 Perform stability testing at predefined intervals (e.g., 0, 1, 3, 6, 9, 12, and 24 months) to monitor product degradation over time.

4.2 Stability Testing Parameters

4.2.1 Visual Inspection

4.2.1.1 Inspect the lyophilized product for color changes, caking, or other visible signs of degradation.

4.2.2 Potency and Purity Testing

4.2.2.1 Conduct potency assays to measure the active ingredient’s efficacy

over time. Additionally, perform purity tests to detect any degradation products.

4.2.3 Moisture Content

4.2.3.1 Use analytical techniques such as Karl Fischer titration to measure the residual moisture content and ensure it remains within acceptable limits throughout storage.

4.3 Documentation

Record all stability testing results in the Stability Testing Logbook, including visual observations, potency, purity, and moisture content data. Ensure that all records are signed off by both the laboratory technician and QA personnel.

5) Abbreviations

QA: Quality Assurance

6) Documents

Stability Testing Logbook

7) References

Pharmacopoeial guidelines for stability testing of pharmaceutical products

8) SOP Version

Version 1.0

Annexure

Stability Testing Logbook Template


  
    Date
    Product Name
    Batch No.
    Testing Results
    Temperature and Storage Conditions
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Product Name
    Batch Number
    Pass/Fail
    Conditions
    Operator Name
    QA Initials

Date	Product Name	Batch No.	Testing Results	Temperature and Storage Conditions	Operator Initials	QA Verification
DD/MM/YYYY	Product Name	Batch Number	Pass/Fail	Conditions	Operator Name	QA Initials