Standard Operating Procedure for Quality Control Testing of IV Injections
1) Purpose
The purpose of this SOP is to define the procedures for quality control testing of intravenous (IV) injections to ensure they meet specifications for safety, efficacy, and quality.
2) Scope
This SOP applies to all personnel involved in the quality control testing of IV injections within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Quality Control (QC) Analysts
- Perform testing according to approved test methods and specifications.
- Record and report test results accurately.
3.2 Quality Assurance (QA) Personnel
- Review and approve QC testing procedures and results.
- Investigate and address any deviations or non-conformities found during testing.
4) Procedure
4.1 Sampling and Testing
- Collect representative samples of IV injections from production batches.
- Perform tests for identity, strength, purity, and particulate matter as per pharmacopeial or internal specifications.
4.2 Analytical Methods
- Use validated analytical methods and instrumentation for testing.
- Calibrate and maintain equipment according to schedule.
4.3 Data Analysis and Interpretation
- Analyze test results against acceptance criteria and specifications.
- Document and report any out-of-specification (OOS) results.
4.4 Retention and Disposal
- Retain representative samples and retain records as per retention schedule.
- Dispose of samples and waste materials according to approved procedures.
5) Abbreviations, if any
SOP: Standard Operating Procedure; QC: Quality Control; QA: Quality Assurance; OOS: Out-of-Specification
6) Documents, if any
- Quality Control Testing Protocols
- Test Result Reports
- Sample Retention and Disposal Records
7) Reference, if any
USP General Chapters <71>, <85>, and <788>: Tests for Sterility, Bacterial Endotoxins, and Particulate Matter in Injections
ICH Q2(R1): Validation of Analytical Procedures
8) SOP Version
Version 1.0