Standard Operating Procedure for Pre-filled Syringe Stability Testing
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting stability testing on pre-filled syringes intended for Intramuscular (IM) and Subcutaneous (SC) injections to ensure the product maintains its quality, safety, and efficacy throughout its shelf life.
2) Scope
This SOP applies to all personnel involved in the stability testing of pre-filled syringes within the pharmaceutical manufacturing facility. It covers the procedures for sample preparation, storage conditions, and stability testing.
3) Responsibilities
– Quality Control (QC) Department: Responsible for performing stability tests and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for stability testing as per the testing protocol.
4) Procedure
4.1 Sample Preparation
4.1.1 Obtain representative samples of pre-filled syringes from production batches.
4.1.2 Ensure samples are properly labeled with batch number, manufacturing date, and intended storage conditions.
4.2 Storage Conditions
4.2.1 Store the samples under the following conditions as specified in the stability protocol:
Long-term: 25°C ± 2°C / 60% RH ± 5% RH
Accelerated: 40°C ± 2°C / 75% RH ± 5% RH
Other conditions as required (e.g., refrigerated or frozen)
4.3 Stability Testing
4.3.1 Conduct stability testing at predefined intervals (e.g., 0, 1, 3, 6, 9, 12, 18, 24 months) as per the stability protocol.
4.3.2 Remove the samples from storage at each testing interval and allow them to equilibrate to room temperature, if necessary.
4.4 Testing Parameters
4.4.1 Perform the following tests on the samples:
Visual inspection for clarity, color, and particulate matter
pH measurement
Potency assay
Sterility testing
Particulate matter testing
Any additional tests as specified in the stability protocol
4.5 Data Analysis
4.5.1 Record all observations and test results in the stability testing logbook or electronic database.
4.5.2 Compare the results against predefined specifications to ensure the product meets the required quality standards.
4.6 Documentation
4.6.1 Document all stability testing results, including raw data and observations.
4.6.2 Ensure that all records are reviewed and approved by the QC department.
4.7 Reporting
4.7.1 Prepare a stability testing report summarizing the methodology, results, and any deviations observed.
4.7.2 Submit the report to the QA department for review and approval.
4.8 Corrective Actions
4.8.1 If any test results do not meet specifications, initiate an investigation to identify the root cause.
4.8.2 Implement corrective actions as necessary and document all findings and actions taken.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
– RH: Relative Humidity
6) Documents, if any
– Stability Testing Logbook
– Stability Testing Reports
– Batch Records
7) Reference, if any
– ICH Q1A(R2): Stability Testing of New Drug Substances and Products
– USP <1> Injections and Implanted Drug Products (Parenterals) – Product Quality Tests
8) SOP Version
Version 1.0
