Stability Study Protocol for Novel Packaging

Stability Study Protocol for Novel Packaging

Comprehensive Stability Study Protocol for Drugs in Novel Packaging

This protocol outlines the procedures for conducting stability studies on drug products in novel packaging systems. The study evaluates how innovative packaging protects drug products from environmental factors, including light, moisture, and oxygen.

Parameter	Details
Product Name	[Product Name]
Batch Number	[Batch Number]
Objective	To evaluate the stability of drugs in novel packaging systems under specified conditions.
Test Parameters	– Assay – Barrier Properties “Shelf Life Code: Prolonging the Potency of Injectable Medications with Extended Stability Measures” – Degradation Products – Physical Integrity
Storage Conditions	[e.g., 25°C/60% RH, 40°C/75% RH]
Test Intervals	[Specify intervals: 0, 3, 6, 12 months, etc.]
Acceptance Criteria	No significant changes in assay, barrier properties, or physical integrity.
Regulatory Guidelines	ICH Q1A(R2), FDA, EMA
Signatories	QA, QC, Regulatory Affairs

See also SOP for Performing Humidity Chamber Studies for Drug Products

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