Standard Operating Procedure for Documentation of Stability Data for Gels
1) Purpose
The purpose of this SOP is to establish procedures for documenting stability data of gels to ensure accurate recording, evaluation, and reporting of product stability over time.
2) Scope
This SOP applies to the Quality Assurance (QA) and Regulatory Affairs departments responsible for documenting stability data for gels at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Assurance (QA): Oversee stability testing procedures and ensure compliance with SOPs and regulatory requirements.
Regulatory Affairs: Compile stability data for regulatory submissions and ensure accuracy and completeness of documentation.
Production: Provide stability samples and assist in data collection as per protocol.
4) Procedure
4.1 Stability Study Design
4.1.1 Develop stability study protocols outlining study objectives, test parameters, and acceptance criteria.
4.1.2 Identify storage conditions (e.g., temperature, humidity) and testing intervals based on product characteristics and regulatory guidelines.
4.2 Sample Collection and Storage
4.2.1 Collect representative samples of gels for stability testing from different batches.
4.2.2 Label and store stability samples under specified storage conditions to maintain sample integrity throughout the study period.
4.3 Stability Testing
4.3.1 Perform stability testing at predefined time points according to
4.3.2 Test samples for physical attributes (e.g., appearance, pH), chemical stability (e.g., active ingredient content), and microbial stability as per requirements.
4.4 Data Evaluation and Reporting
4.4.1 Evaluate stability data to determine product shelf-life and storage recommendations.
4.4.2 Prepare stability reports summarizing study results, conclusions, and any deviations encountered during testing.
4.5 Documentation and Recordkeeping
4.5.1 Maintain accurate and complete records of stability study protocols, testing procedures, and results.
4.5.2 Archive stability data and reports for regulatory submissions, internal audits, and future reference as per regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Stability Study Protocols
– Stability Testing Reports
– Stability Data Sheets
7) Reference, if any
– ICH guidelines on stability testing of pharmaceutical products
– Regulatory requirements for stability data documentation (e.g., FDA, EMA)
8) SOP Version
Version 1.0