Standard Operating Procedure for Stability Testing of Intravenous (IV) Injections

1) Purpose

The purpose of this SOP is to establish a standardized procedure for conducting stability testing of intravenous (IV) injections to ensure their safety, efficacy, and quality throughout the product’s shelf life.

2) Scope

This SOP applies to all IV injection products manufactured and tested within the facility. It covers the procedures for sampling, testing, and documentation of stability studies.

3) Responsibilities

3.1 Stability Coordinator
– Oversee the stability testing program.
– Ensure proper storage conditions and timely testing of samples.
3.2 Quality Control (QC) Personnel
– Conduct stability tests as per the protocol.
– Record and report test results accurately.
3.3 Quality Assurance (QA) Personnel
– Review and approve stability study protocols and reports.
– Ensure compliance with regulatory guidelines.

4) Procedure

4.1 Preparation for Stability Testing
4.1.1 Develop a stability protocol outlining the study design, including sample size, storage conditions, and testing intervals.
4.1.2 Select and label samples from each batch of IV injections for stability testing.
4.2 Storage Conditions
4.2.1 Store samples under specified conditions (e.g., temperature, humidity) as per the stability protocol.
4.2.2 Monitor and record storage conditions regularly to ensure compliance.
4.3 Testing Intervals
4.3.1 Conduct stability testing at predetermined intervals (e.g., initial, 3 months, 6 months, 12 months, etc.).
4.3.2 Perform tests such as appearance, pH, potency, sterility, and particulate matter.
4.4 Testing Procedures
4.4.1 Follow validated analytical methods for each test parameter.
4.4.2 Use calibrated equipment and maintain proper documentation of calibration records.
4.5 Data Analysis and Reporting
4.5.1 Analyze test results and compare them with initial values and acceptance criteria.
4.5.2 Document findings in stability reports and summarize trends and deviations.
4.6 Stability Reports
4.6.1 Compile and review stability data periodically.
4.6.2 Submit stability reports to regulatory authorities as required.

5) Abbreviations, if any

– IV: Intravenous
– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Stability Protocol
– Stability Testing Records
– Stability Reports

7) Reference, if any

– International Council for Harmonisation (ICH) Guidelines Q1A (R2): Stability Testing of New Drug Substances and Products
– United States Pharmacopeia (USP) General Chapter <1225> Validation of Compendial Procedures

8) SOP Version

Version 1.0