PHARMACEUTICAL PACKAGING INTEGRITY CHECKLIST

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--- PRIMARY PACKAGING MATERIAL ASSESSMENT ---
[ ] Material Specification Review Summary
[ ] Material Lot Status (Approved, Pending Approval, Rejected)
[ ] Material Thickness (mm)
[ ] Density (g/cm³)
[ ] Material Certificate of Analysis (CoA)
[ ] Drug Compatibility Assessment Status (Complete, In Progress, Not Required)
[ ] Observed Material Characteristics

--- CONTAINER CLOSURE SEALING INTEGRITY ---
[ ] Vacuum Leak Test Pressure (inches of water)
[ ] Vacuum Leak Test Duration (seconds)
[ ] Leak Test Result (Pass, Fail, NA)
[ ] Leak Test Failure Description (if applicable)
[ ] Dye Penetration Test Performed? (Yes, No)
[ ] Seal Image (if applicable)
[ ] Seal Strength (N)
[ ] Leak test performed date

--- DIMENSIONAL ACCURACY & TOLERANCES ---
[ ] Container Height (mm)
[ ] Container Diameter/Width (mm)
[ ] Label Height (mm)
[ ] Label Width (mm)
[ ] Closure Height (mm)
[ ] Closure Diameter (mm)
[ ] Measurement Unit (mm, cm, inches)

--- LABELING & IDENTIFICATION ---
[ ] Product Name
[ ] Batch Number
[ ] Manufacturing Date
[ ] Expiry Date
[ ] Label Orientation (Vertical, Horizontal)
[ ] Label Material (Paper, Polypropylene, Other)
[ ] Label Image (for Reference)

--- PACKAGING PERFORMANCE TESTING ---
[ ] Drop Height (cm)
[ ] Vibration Frequency (Hz)
[ ] Temperature (Celsius)
[ ] Humidity (%)
[ ] Observed Damage (if any)
[ ] Pass/Fail Result (Pass, Fail)
[ ] Test Date
[ ] Test Data/Images

--- TAMPER EVIDENCE EVALUATION ---
[ ] Tamper-Evident Feature Type (Child-Resistant Closure, Sealed Unit Dose, Blister Pack, Shrink Wrap, Tamper-Evident Tape)
[ ] Number of Tamper Indications Present
[ ] Indicator Integrity Status (Intact, Compromised, Missing)
[ ] Detailed Observation of Tamper Evidence
[ ] Supporting Photographs
[ ] Compliance with Specifications (Compliant, Non-Compliant, Not Applicable)

--- STATISTICAL SAMPLING PLAN VERIFICATION ---
[ ] Sample Size (n)
[ ] Acceptance Quality Limit (AQL)
[ ] Sampling Method (Random Sampling, Systematic Sampling, Stratified Sampling)
[ ] Lot Size
[ ] Justification for Sampling Plan Selection
[ ] Criticality of Defect (Critical, Major, Minor)
[ ] Sampling Plan Review Date

--- DOCUMENTATION REVIEW ---
[ ] Document Review Date
[ ] Document Status (Reviewed/Approved/Rejected) (Reviewed, Approved, Rejected)
[ ] Review Comments/Observations
[ ] Supporting Documentation (e.g., Test Reports)
[ ] Reviewer Signature
[ ] Document Revision Number

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