Pharma Stability: Insights, Guidelines, and Expertise
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…
Read More “SOP for Determining the Commencement Date for Stability Testing” »
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…
Read More “SOP for Determining the ‘Due Dates’ for a Stability Study Protocol” »
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…
Read More “SOP for Generating the T-Zero Certificate of Analysis for Stability Studies” »
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….
Read More “SOP for Defining Parameters 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…
Read More “SOP for Defining Acceptance Criteria for Stability Testing” »
Preparing a Schedule for Withdrawal of Stability Samples Completing Storage Period Purpose The purpose of this SOP is to outline the procedure for preparing a schedule for the withdrawal of stability samples that have completed their designated storage period. Scope This SOP applies to all stability studies conducted within the pharmaceutical company where samples are…
Determining Batch Quantity and Size for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for determining the number and size of batches required for stability testing to ensure representativeness, consistency, and regulatory compliance. Scope This SOP applies to all stability studies conducted on drug substances and drug…
Read More “SOP for Number and Size of Batches for Stability Testing” »
Determining Sample Quantity for Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for determining the number of samples required for performing stability tests to ensure adequate and representative sampling throughout the study duration. Scope This SOP applies to all stability studies conducted on drug substances and drug…
Read More “SOP for Number of Samples Required for Performing Stability Tests” »
Sample Labeling Procedure for Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for labeling stability study samples to ensure accurate identification, traceability, and compliance with regulatory requirements. Scope This SOP applies to all stability study samples of drug substances and drug products within the pharmaceutical company’s…
Sample Storage Setup for Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for configuring the storage environment for stability study samples to ensure consistency, compliance, and integrity of the samples. Scope This SOP applies to all stability study samples of drug substances and drug products within the…
Read More “SOP for Storage Configuration of Samples in a Stability Environment” »