PHARMACEUTICAL STABILITY PROGRAM CHECKLIST

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--- PROGRAM SETUP & DOCUMENTATION ---
[ ] Program Scope and Objectives
[ ] Program SOP (Standard Operating Procedure)
[ ] Regulatory Framework Compliance (e.g., ICH, FDA) (ICH Guidelines, FDA Regulations, Other (Specify))
[ ] Program Implementation Date
[ ] Document Control Number
[ ] Responsibilities and Roles Defined
[ ] Program Owner Approval

--- PROTOCOL DEVELOPMENT ---
[ ] Rationale for Selected Storage Conditions
[ ] Container Closure System (Primary Packaging, Secondary Packaging, Both)
[ ] Number of Replicates per Batch
[ ] Start Date of Stability Study
[ ] Time Points for Testing (Months)
[ ] Parameters to be Tested (Appearance, Assay, Impurities, Moisture Content, pH)
[ ] Acceptance Criteria for Assay

--- SAMPLE SELECTION & HANDLING ---
[ ] Batch Number
[ ] Number of Samples Selected
[ ] Packaging Configuration (Primary Packaging Only, Primary & Secondary Packaging, Bulk Material)
[ ] Sample Collection Date
[ ] Storage Condition Assignment (25°C/60%RH, 30°C/65%RH, Cool (2-8°C), Freezer (-20°C))
[ ] Sample Labeling Details
[ ] Sample Storage Location

--- TESTING & DATA ANALYSIS ---
[ ] Batch Number
[ ] Testing Start Date
[ ] Testing Start Time
[ ] Temperature (°C)
[ ] Humidity (%)
[ ] pH Value
[ ] Assay Result (%)
[ ] Impurity A (ppm)
[ ] Analytical Method (HPLC, GC, UV-Vis)

--- TRENDING & REPORTING ---
[ ] Batch Size Analyzed
[ ] Report Generation Date
[ ] Summary of Trending Observations
[ ] Overall Stability Status (Based on Trending) (Acceptable, Questionable, Unacceptable)
[ ] Number of Batches Included in Trend Analysis
[ ] Justification for Stability Status
[ ] Next Review Date of Trending Data

--- DEVIATION MANAGEMENT & CAPA ---
[ ] Deviation Number
[ ] Deviation Date
[ ] Description of Deviation
[ ] Deviation Severity (Minor, Moderate, Major)
[ ] Root Cause Analysis
[ ] Corrective Action Plan
[ ] Corrective Action Completion Date
[ ] CAPA Approval Signature
[ ] Related Documents/Records (Batch Record, SOP, Analytical Report, Investigation Report)

--- PERIODIC REVIEW & UPDATES ---
[ ] Last Review Date
[ ] Summary of Review Findings
[ ] Areas Requiring Updates? (Protocols, Acceptance Criteria, Testing Methods, Archiving Procedures, Regulatory Requirements)
[ ] Rationale for Changes
[ ] Next Review Cycle Length (Months)
[ ] Impact Assessment? (Minor, Moderate, Major)
[ ] Reviewer Signature

--- ARCHIVING & DATA RETENTION ---
[ ] Date of Data Archiving
[ ] Summary of Archiving Process
[ ] Number of Files Archived
[ ] Archiving Confirmation Document
[ ] Archiving Location (Electronic Archive, Physical Archive)
[ ] Retention Period (Years)
[ ] Description of Security Measures for Archive

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