Tag: Stability analysis

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

SOP for Commencing Stability Testing

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…

Stability Studies SOP

SOP for Stability Protocol Documentation Requirements

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…

Stability Studies SOP

SOP for Determining the Commencement Date for Stability Testing

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…

Stability Studies SOP

SOP for Determining the ‘Due Dates’ for a Stability Study Protocol

Establishing With-drawal dates for Stability Study sample Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for determining the ‘due dates’ for various milestones in a stability study protocol to ensure timely completion and regulatory compliance. Scope This SOP applies to all stability studies conducted on drug substances and drug…

Stability Studies SOP

SOP for Generating the T-Zero Certificate of Analysis for Stability Studies

The Initial Certificate of Analysis at T-Zero for a Stability Study Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for generating the initial Certificate of Analysis (CoA) at time zero (T0) for a stability study to ensure accurate and comprehensive documentation of the initial condition of the drug substance…

Stability Studies SOP

SOP for Defining Parameters for Stability Testing

Study Parameters for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to define and document the study parameters for stability studies, ensuring consistency, accuracy, and regulatory compliance throughout the testing process. Scope This SOP applies to all stability studies conducted on drug substances and drug products within the pharmaceutical company’s facilities….

Stability Studies SOP

SOP for Defining Acceptance Criteria for Stability Testing

Setting Limits for Check Specifications in a Stability Study Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the process for setting limits for check specifications in a stability study to ensure consistency, accuracy, and compliance with regulatory requirements. Scope This SOP applies to all stability studies conducted on drug substances and…

Stability Studies SOP