Standard Operating Procedure for Stability Testing of IM and SC Products
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting stability testing of Intramuscular (IM) and Subcutaneous (SC) products to assess their quality, safety, and efficacy over time.
2) Scope
This SOP applies to all personnel involved in stability testing within the pharmaceutical manufacturing facility. It covers procedures for stability study design, sample storage, testing, and documentation.
3) Responsibilities
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Quality Control (QC) Department: Conducts stability testing and analyzes stability data.
– Production Department: Provides stability samples and supports testing activities as required.
4) Procedure
4.1 Stability Study Design – QA: Quality Assurance – Stability Study Protocol – ICH Guidelines for Stability Testing of New Drug Substances and Products Version 1.0
4.1.1 Define the objectives, testing parameters, and storage conditions for the stability study.
4.1.2 Select representative batches of IM and SC products for testing based on manufacturing history and formulation.
4.2 Sample Storage
4.2.1 Store stability samples in appropriate containers under controlled environmental conditions (temperature, humidity).
4.2.2 Monitor storage conditions continuously and record environmental data at regular intervals.
4.3 Stability Testing
4.3.1 Perform stability testing at defined time points according to the study protocol (e.g., 3 months, 6 months, 12 months).
4.4 Data Analysis
4.4.1 Analyze stability data to assess product degradation trends and establish shelf-life estimates.
4.4.2 Evaluate test results against acceptance criteria to determine product stability and compatibility.
4.5 Documentation
4.5.1 Document all aspects of the stability testing program, including study protocols, test methods, and analytical results.
4.5.2 Ensure that all records are reviewed and approved by the QA department.
4.6 Reporting
4.6.1 Prepare a stability study report summarizing study objectives, methodology, results, and conclusions.
4.6.2 Submit the report to the QA department for review and approval.
4.7 Corrective Actions
4.7.1 Address any deviations or out-of-specification results identified during stability testing.
4.7.2 Implement corrective actions to mitigate risks and ensure ongoing product stability.
5) Abbreviations, if any
– QC: Quality Control
– IM: Intramuscular
– SC: Subcutaneous6) Documents, if any
– Stability Study Report
– Environmental Monitoring Records7) Reference, if any
– FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products8) SOP Version
