Tag: Regulatory requirements

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

SOP for Stability Sample With-drawal Schedule

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…

Stability Studies SOP

SOP for Number and Size of Batches for Stability Testing

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…

Stability Studies SOP

SOP for Number of Samples Required for Performing Stability Tests

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…

Stability Studies SOP

SOP for Labeling of Stability Study Samples

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…

Stability Studies SOP

SOP for Storage Configuration of Samples in a Stability Environment

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…

Stability Studies SOP

SOP for Storing the Stability Study Samples Under Controlled Conditions Prior to Analysis

Controlled Storage of Stability Study Samples Before Analysis Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for storing stability study samples under controlled conditions prior to analysis to ensure sample integrity and compliance with regulatory requirements. Scope This SOP applies to all stability study samples of drug substances and drug…

Stability Studies SOP

SOP for Stress Testing the Bulk Drug Substance

Conducting Stress Tests on Bulk Drug Substances for Stability Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting stress tests on bulk drug substances to assess their stability under various stress conditions, thereby identifying potential degradation products and establishing degradation pathways. Scope This SOP applies to all…

Stability Studies SOP

SOP for Intervals and Climatic Conditions for a US Pivotal/Bioequivalence Stability Study

Scheduling and Environmental Conditions for US Pivotal/Bioequivalence Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to define the intervals and climatic conditions for conducting pivotal or bioequivalence stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability data…

Stability Studies SOP

SOP for Intervals and Climatic Conditions for a US Development Stability Study

Scheduling and Environmental Conditions for US Stability Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the intervals and climatic conditions for conducting stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability data. Scope This SOP applies…

Stability Studies SOP