Guidelines for Stability Testing of Vaccines as per WHO Guidelines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability studies for vaccines in accordance with World Health Organization (WHO) guidelines. This SOP ensures that stability data supports the quality, safety, and efficacy of vaccines throughout their shelf life.
2) Scope
This SOP applies to all personnel involved in the design, execution, and documentation of stability studies for vaccines intended for global markets.
3) Responsibilities
Stability Testing Team: Responsible for conducting stability studies and documenting results in compliance with WHO guidelines.
Quality Assurance (QA) Team: Responsible for reviewing and approving stability study protocols and reports.
Regulatory Affairs Team: Responsible for ensuring that stability studies meet the regulatory expectations of target markets.
4) Procedure
4.1 Preparation for Stability Testing
4.1.1 Obtain and review the latest WHO guidelines for stability testing of vaccines.
4.1.2
4.2 Selection of Batches and Samples
4.2.1 Select representative batches of the vaccine, typically three primary batches manufactured using the proposed production process.
4.2.2 Prepare sufficient samples to cover the entire study duration, considering
4.3 Defining Storage Conditions and Time Points
4.3.1 Define the storage conditions according to WHO guidelines, typically including:
- Refrigerated stability: 2°C to 8°C
- Accelerated stability: 25°C ± 2°C/60% RH ± 5% RH
4.3.2 Establish the time points for sampling, such as 0, 3, 6, 9, 12, 18, and 24 months for long-term studies, and additional time points for accelerated studies.
4.4 Conducting Stability Tests
4.4.1 Store samples under the defined conditions, ensuring that the cold chain is maintained and monitoring temperature and humidity as required.
4.4.2 At each specified time point, remove samples and conduct stability-indicating tests, including potency, sterility, and safety tests, as applicable.
4.4.3 Record all results meticulously in stability data sheets, ensuring accuracy and traceability of data.
5) Abbreviations, if any
WHO: World Health Organization
QA: Quality Assurance
RH: Relative Humidity
6) Documents, if any
Stability protocol, stability data sheets, stability testing records, stability report, submission package to regulatory authorities.
7) Reference, if any
WHO Guidelines on Stability Testing of Vaccines.
8) SOP Version
Version 1.0