Procedure for Stability Testing of Combination Antiretroviral Therapy (cART)
1) Purpose
The purpose of this SOP is to establish a procedure for conducting stability testing for combination antiretroviral therapy (cART) in compliance with relevant regulatory guidelines. This ensures that cART products maintain their safety, efficacy, and quality throughout their shelf life.
2) Scope
This SOP applies to all personnel involved in the stability testing of combination antiretroviral therapy (cART) products, including formulation development, quality control, and regulatory affairs teams.
3) Responsibilities
Formulation Development Team: Responsible for developing cART formulations and selecting suitable packaging materials.
Stability Study Team: Responsible for conducting stability studies according to approved protocols.
Regulatory Affairs Team: Responsible for ensuring compliance with relevant guidelines and submitting stability data to regulatory authorities.
4) Procedure
4.1 Protocol Development
4.1.1 Develop a stability testing protocol that includes parameters specific to cART products, such as assay, dissolution, degradation products,
4.1.2 Define storage conditions (e.g., room temperature, refrigerated) and testing intervals based on regulatory guidelines.
4.2 Sample Preparation and Storage
4.2.1 Prepare samples in their final packaging for stability testing.
4.2.2 Store samples under specified conditions according to the protocol.
4.3 Conducting Stability Tests
4.3.1 Perform stability tests at all required intervals.
4.3.2 Document all data accurately and ensure compliance with the approved protocol.
4.4 Data Analysis and Reporting
4.4.1 Analyze stability data to identify any trends or deviations that may affect product performance.
4.4.2 Prepare a stability report for regulatory submission.
5) Abbreviations, if any
cART: Combination Antiretroviral Therapy
6) Documents, if any
6.1 Stability testing protocols
6.2 Data sheets
6.3 Stability reports
7) Reference, if any
FDA Guidance for Industry: Stability Testing of Combination Antiretroviral Therapy, WHO Guidelines for Antiretroviral Therapy
8) SOP Version
Version 1.0