Tag: Stability testing guidelines

Role of Stability Studies in Ensuring Product Safety

Stability studies are fundamental in the pharmaceutical industry for evaluating the safety of medicinal products throughout their shelf life. These studies provide critical data on how the quality, efficacy, and safety of a product may change over time under various storage conditions. By assessing stability, pharmaceutical companies can ensure that their products remain safe for…

Stability Studies Blog

Effect of Humidity in Stability Studies

Humidity is a critical environmental factor that can significantly impact the stability of pharmaceutical products. Fluctuations in humidity levels can lead to moisture uptake or loss, potentially causing physical, chemical, and microbiological changes in the product. Therefore, stability studies must carefully account for the effects of humidity to ensure the quality, safety, and efficacy of…

Stability Studies Blog

Standard template for Calibration Certificates and Results

Calibration Certificate Instrument Details Instrument Name [Instrument Name] Instrument ID [Instrument ID] Manufacturer [Manufacturer Name] Model [Model Number] Serial Number [Serial Number] Location [Location] Calibration Details Calibration Date [Calibration Date] Next Calibration Due [Next Calibration Due Date] Calibrated By [Name of Person/Company] Environmental Conditions [Environmental Conditions] Calibration Results Standard Value Instrument Reading Deviation Pass/Fail [Standard…

Stability Documentation

Standard template for Functional Test Results

Functional Test Results Test Details Test Name [Test Name] Test ID [Test ID] Test Date [Test Date] Tested By [Tested By] Location [Location] Test Specifications Specification Expected Result Actual Result Pass/Fail [Specification 1] [Expected Result 1] [Actual Result 1] [Pass/Fail 1] [Specification 2] [Expected Result 2] [Actual Result 2] [Pass/Fail 2] [Specification 3] [Expected Result…

Stability Documentation

Standard template for Stress Testing Logs

Stress Testing Logs Test Details Test Name [Test Name] Test ID [Test ID] Test Date [Test Date] Tested By [Tested By] Location [Location] Test Parameters Parameter Value Unit [Parameter 1] [Value 1] [Unit 1] [Parameter 2] [Value 2] [Unit 2] [Parameter 3] [Value 3] [Unit 3] Test Results Time Observation Notes [Time 1] [Observation 1]…

Stability Documentation

Standard template for Audit Reports

Audit Report Audit Details Audit Title [Audit Title] Audit ID [Audit ID] Audit Date [Audit Date] Auditor Name [Auditor Name] Location [Location] Audit Scope [Audit Scope] Audit Objectives [Audit Objectives] Audit Findings Finding ID Description Severity Corrective Action Responsible Person Due Date [Finding ID 1] [Description 1] [Severity 1] [Corrective Action 1] [Responsible Person 1]…

Stability Documentation

Standard template for Packaging of Stability Samples

Packaging of Stability Samples Packaging Details Sample ID [Sample ID] Batch Number [Batch Number] Product Name [Product Name] Packaging Date [Packaging Date] Packed By [Packed By] Packaging Materials Material Specification Quantity Lot Number [Material 1] [Specification 1] [Quantity 1] [Lot Number 1] [Material 2] [Specification 2] [Quantity 2] [Lot Number 2] [Material 3] [Specification 3]…

Stability Documentation

Standard template for Certification of a Container-Liner-Closure System

Certification of Container-Liner-Closure System Certification Details Certification ID [Certification ID] Date [Date] Certified By [Certified By] Approved By [Approved By] Container Details Container Type [Container Type] Container Material [Container Material] Container Size [Container Size] Manufacturer [Manufacturer] Batch Number [Batch Number] Liner Details Liner Type [Liner Type] Liner Material [Liner Material] Liner Size [Liner Size] Manufacturer…

Stability Documentation

Standard template for Sample Collection and Labeling Records

Sample Collection and Labeling Records Sample Collection Details Collection ID [Collection ID] Collection Date [Collection Date] Collected By [Collected By] Location [Location] Sample Type [Sample Type] Batch Number [Batch Number] Sample Labeling Details Sample ID [Sample ID] Product Name [Product Name] Batch Number [Batch Number] Storage Condition [Storage Condition] Expiry Date [Expiry Date] Additional Information…

Stability Documentation

Standard template for a Stability Protocol

Stability Protocol Purpose The purpose of this stability protocol is to outline the procedures for conducting stability studies on [Product Name] to determine its shelf life and ensure its quality, safety, and efficacy over time. Scope This protocol applies to the stability testing of [Product Name] manufactured by [Company Name]. Responsibilities Stability Coordinator: Oversee the…

Stability Documentation