Standard Operating Procedure for Temperature Cycling Testing for Creams
1) Purpose
The purpose of this SOP is to define procedures for conducting temperature cycling testing on creams. This ensures that creams remain stable and maintain quality under conditions of temperature variation, simulating real-world storage and transportation scenarios.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting temperature cycling testing of creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing temperature cycling testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Equipment Setup
4.1.1 Prepare temperature cycling chambers or equipment according to manufacturer instructions.
4.1.2 Verify the calibration status of temperature sensors and controllers before testing begins.
4.1.3 Ensure all necessary safety precautions are in place.
4.2 Sample Preparation
4.2.1 Select representative samples of creams from the batch for testing.
4.2.2 Label each sample with batch information and identification numbers.
4.2.3 Ensure samples are equilibrated to room temperature before testing.
4.3 Temperature Cycling Procedure
4.3.1 Place cream samples into the temperature cycling chambers.
4.3.2 Cycle samples through specified temperature ranges (e.g., -20°C to +40°C) for defined durations, simulating transportation and storage conditions.
4.3.3 Ensure gradual transitions between temperature extremes to prevent thermal shock.
4.4 Monitoring and Evaluation
4.4.1 Monitor temperature and humidity levels throughout the testing period.
4.4.2 Assess samples at defined intervals for changes in physical appearance, texture, consistency, and other quality attributes.
4.4.3 Record observations and measurements of any changes or deviations from baseline characteristics.
4.5 Acceptance Criteria
4.5.1 Establish acceptance criteria based on regulatory requirements and product-specific considerations (e.g., no significant changes in appearance or properties).
4.5.2 Evaluate test results against acceptance criteria to determine pass or fail status for each sample.
4.5.3 Document and justify acceptance or rejection decisions based on test results.
4.6 Documentation and Reporting
4.6.1 Document all temperature cycling testing activities, including equipment setup, test methods, procedures, results, and observations.
4.6.2 Prepare temperature cycling testing reports summarizing test conditions, results, conclusions, and recommendations.
4.6.3 Obtain approval from Quality Control Management for temperature cycling testing reports.
4.7 Retesting and Non-Conforming Samples
4.7.1 Retest samples that fail to meet acceptance criteria using the same or modified temperature cycling conditions.
4.7.2 Segregate and quarantine non-conforming samples to prevent unintended distribution or use.
4.7.3 Investigate root causes of non-conforming results and implement corrective actions to prevent recurrence.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
ISO: International Organization for Standardization
6) Documents, if any
Temperature Cycling Testing Protocols
Temperature Cycling Testing Reports
Non-Conforming Material Reports
Corrective Action Reports
7) Reference, if any
ICH Q1A (R2): Stability Testing of New Drug Substances and Products
USP
8) SOP Version
Version 1.0