Standard Operating Procedure for Quality Control Testing of IV Injections
1) Purpose
The purpose of this SOP is to define the procedures for conducting quality control testing of intravenous (IV) injections to ensure compliance with specifications and regulatory requirements.
2) Scope
This SOP applies to all quality control personnel responsible for testing IV injections in the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Quality Control (QC) Analysts
- Perform testing and analysis of IV injections according to approved testing protocols.
- Record and report testing results accurately and promptly.
3.2 Quality Assurance (QA) Personnel
- Review and approve testing procedures and results.
- Ensure compliance with specifications and regulatory requirements.
4) Procedure
4.1 Sample Preparation
- Retrieve representative samples of IV injections from production.
- Prepare samples according to testing protocols, including dilution if necessary.
4.2 Testing Methods
- Perform physical tests such as visual inspection and particulate matter testing.
- Conduct chemical tests including pH testing, conductivity testing, and assay determination.
4.3 Microbiological Testing
- Perform sterility testing and endotoxin testing as per pharmacopeial or regulatory requirements.
- Use validated methods and controls to ensure accurate and reliable results.
4.4 Data Analysis and Reporting
- Analyze testing data and compare results against acceptance criteria.
- Document testing outcomes and report deviations or non-conformances as necessary.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
- Testing Protocols
- Testing Records and Reports
- Validation Reports for Testing Methods
7) Reference, if any
USP General Chapters related to IV injections (e.g., <797>, <85>, <161>)
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
8) SOP Version
Version 1.0