Standard Operating Procedure for Stability Testing of Intramuscular (IM) and Subcutaneous (SC) Injections

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting stability testing of Intramuscular (IM) and Subcutaneous (SC) injections to ensure their safety, efficacy, and quality over the product’s intended shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of IM and SC injections within the pharmaceutical manufacturing facility. It covers the processes from sample preparation to data recording and reporting.

3) Responsibilities

– Quality Control (QC) Department: Responsible for conducting the stability tests and recording data.
– Quality Assurance (QA) Department: Responsible for reviewing and approving stability test results and ensuring compliance with regulatory guidelines.
– Production Department: Responsible for providing samples for stability testing as per the stability protocol.
– Regulatory Affairs: Ensures that the stability testing complies with regulatory requirements and guidelines.

4) Procedure

4.1 Sample Preparation
4.1.1 Select representative samples of IM and SC injections from each batch as per the stability protocol.
4.1.2 Label samples with unique identifiers, including batch number, storage conditions, and testing intervals.
4.2 Storage Conditions
4.2.1 Store samples under specified conditions such as long-term, intermediate, and accelerated stability testing conditions.
4.2.2 Typical conditions include:
Long-term: 25°C ± 2°C / 60% RH ± 5% RH
Intermediate: 30°C ± 2°C / 65% RH ± 5% RH
Accelerated: 40°C ± 2°C / 75% RH ± 5% RH
4.3 Testing Intervals
4.3.1 Conduct stability tests at predetermined intervals, such as 0, 3, 6, 9, 12, 18, and 24 months for long-term stability.
4.3.2 Intermediate and accelerated testing intervals may vary as per the stability protocol.
4.4 Stability Testing
4.4.1 Perform the following tests on stability samples:
Appearance
pH
Assay (potency)
Degradation products
Particulate matter
Sterility
Container closure integrity
4.5 Data Recording and Analysis
4.5.1 Record all test results in the stability testing logbook or electronic database.
4.5.2 Compare the results against predefined specifications to determine any significant changes.
4.6 Reporting
4.6.1 Compile stability data and prepare stability reports at the end of each testing interval.
4.6.2 Submit the stability reports to the QA department for review and approval.
4.7 Corrective Actions
4.7.1 If any stability parameter fails to meet specifications, initiate an investigation to identify the root cause.
4.7.2 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 Protocol
– Stability Testing Logbook
– Stability Reports
– Batch Records

7) Reference, if any

– ICH Q1A(R2): Stability Testing of New Drug Substances and Products
– FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products

8) SOP Version

Version 1.0