Standard Operating Procedure for Documentation of Stability Data for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the documentation of stability data generated during stability testing of aerosol products to ensure data integrity, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to the documentation of stability data for aerosol products at [Company Name], including data management, recordkeeping, and reporting procedures.
3) Responsibilities
Quality Assurance (QA) Team: Oversee compliance with SOPs for stability data documentation.
Stability Testing Team: Generate and document stability data as per approved protocols.
Regulatory Affairs: Review and approve stability data documentation for regulatory submissions.
Data Management Team: Maintain stability data records and ensure data integrity.
4) Procedure
4.1 Data Recording and Entry:
4.1.1 Record stability testing parameters, conditions, and observations in a designated stability data logbook or electronic system.
4.1.2 Ensure accurate and timely entry of stability data into the designated data management system.
4.1.3 Include relevant metadata such as batch numbers, testing dates, and storage conditions for each stability study.
4.2 Data Review and Approval:
4.2.1 Review stability data for completeness, accuracy, and compliance with predefined acceptance criteria.
4.2.2 Verify calculations, graphical representations, and trend analyses of stability data.
4.2.3
4.3 Data Retention and Archiving:
4.3.1 Maintain stability data records in accordance with company policies and regulatory guidelines.
4.3.2 Archive stability data in a secure and accessible manner to facilitate retrieval for regulatory inspections or internal audits.
4.3.3 Implement data backup procedures to prevent loss of stability data due to system failures or data corruption.
4.4 Reporting and Documentation:
4.4.1 Prepare stability study reports summarizing study objectives, methods, results, and conclusions.
4.4.2 Include stability data summaries and trend analyses in regulatory submissions as required.
4.4.3 Document any deviations or out-of-specification (OOS) results observed during stability testing and their resolution.
4.5 Data Security and Confidentiality:
4.5.1 Ensure confidentiality and integrity of stability data through controlled access and data encryption measures.
4.5.2 Restrict access to stability data records to authorized personnel only, as per company data security policies.
4.5.3 Comply with data protection regulations (e.g., GDPR, HIPAA) when handling stability data involving personal or sensitive information.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
OOS: Out-of-Specification
GDPR: General Data Protection Regulation
6) Documents, if any
Stability Data Logbook or Electronic System
Stability Study Reports
Regulatory Submissions
Deviation and OOS Reports
Data Backup and Archival Records
7) Reference, if any
FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
ICH Guidelines for Stability Testing
Company-Specific Data Management Policies and Procedures
8) SOP Version
Version 1.0