Pharma Stability: Insights, Guidelines, and Expertise
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…
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]…
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]…
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]…
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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…
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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…
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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…
Initiating a Stability Study Purpose The purpose of this Standard Operating Procedure (SOP) is to provide a step-by-step process for initiating a stability study, ensuring that all necessary preparations and documentation are completed to comply with regulatory requirements. Scope This SOP applies to all stability studies conducted on drug substances and drug products within the…
Contents of a Stability Protocol Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the essential components and format required for a stability protocol to ensure comprehensive and consistent documentation for stability studies. Scope This SOP applies to all stability protocols prepared for stability studies on drug substances and drug products within…
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Setting the ‘Start Date’ for a Stability Study Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for setting the ‘start date’ for a stability study to ensure consistency and compliance with regulatory requirements. Scope This SOP applies to all stability studies conducted on drug substances and drug products within…
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