Tag: Stability testing

SOP for Preparing a Stability Protocol in Accordance with ICH Q1A(R2)

SOP for Preparing a Stability Protocol in Accordance with ICH Q1A(R2) Guidelines for Developing a Stability Protocol as per ICH Q1A(R2) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for preparing a stability protocol for drug substances and drug products in compliance with the ICH Q1A(R2) guidelines. This…

Stability Studies SOP

Submit at Least 6 Months of Long-Term Data for New Drug Applications

Understanding the Tip: Why 6 months of data is the baseline: New drug applications (NDAs) require scientific evidence to justify proposed shelf life and storage conditions. At least 6 months of real-time, long-term stability data is the regulatory minimum needed to establish preliminary product behavior over time. This data provides an early trend of degradation,…

Stability Study Tips

Ensure Packaging Justification Is Based on Stability Data and Product Sensitivity

Understanding the Tip: Why packaging decisions must be data-driven: Primary packaging plays a critical role in protecting a drug product from environmental factors like moisture, oxygen, and light. Choosing the right material must go beyond aesthetics or cost—it should be backed by product-specific stability data. Aligning packaging with the product’s sensitivity ensures that efficacy, safety,…

Stability Study Tips

Follow ICH-Compliant Sampling Intervals for Accurate Stability Assessment

Understanding the Tip: Why structured sampling intervals matter: Stability testing isn’t just about storing products—it’s about analyzing them at critical intervals to track changes over time. Structured sampling intervals are essential to detect degradation trends and determine shelf life accurately. Missing key time points can lead to incomplete datasets, failed regulatory audits, or inaccurate product…

Stability Study Tips

SOP for Conducting Stability Studies in Compliance with Japanese Regulatory Requirements (PMDA)

SOP for Conducting Stability Studies in Compliance with Japanese Regulatory Requirements (PMDA) Standard Operating Procedure for Stability Testing According to PMDA Guidelines 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies in compliance with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) guidelines to ensure the safety,…

Stability Studies SOP

SOP for Managing Stability Testing of Post-Approval Changes According to US FDA Guidelines

SOP for Managing Stability Testing of Post-Approval Changes According to US FDA Guidelines Standard Operating Procedure for Stability Testing Following Post-Approval Changes 1) Purpose The purpose of this SOP is to provide a standardized approach for managing stability testing following post-approval changes to drug substances and products in compliance with US FDA guidelines.

Stability Studies SOP

Follow ICH Q1B for Photostability Testing Using Appropriate Light Sources

Understanding the Tip: Why photostability testing is important: Many pharmaceutical products are susceptible to light-induced degradation, which can lead to reduced potency, the formation of harmful impurities, or changes in physical appearance. Photostability testing identifies these risks early. This allows manufacturers to define appropriate packaging and labeling that protect the product and extend shelf life….

Stability Study Tips

SOP for Applying ICH Q1C Guidelines for Stability Testing of New Dosage Forms

SOP for Applying ICH Q1C Guidelines for Stability Testing of New Dosage Forms Standard Operating Procedure for Stability Testing of New Dosage Forms as per ICH Q1C 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability testing of new dosage forms in compliance with ICH Q1C guidelines to…

Stability Studies SOP

Why Stability Chambers Must Be Validated and Mapped Accurately

Understanding the Tip: Why chamber validation is essential: Stability chambers simulate environmental conditions that pharmaceutical products may face during their shelf life. If these chambers are not properly validated, the entire stability study becomes unreliable. Validation ensures that the chamber consistently maintains programmed temperature and humidity conditions within specified limits, safeguarding the integrity of the…

Stability Study Tips

SOP for Developing Stability Study Reports for ANDA Submissions

SOP for Developing Stability Study Reports for ANDA Submissions Standard Operating Procedure for Preparing Stability Reports for ANDAs 1) Purpose The purpose of this SOP is to provide a standardized procedure for developing stability study reports for Abbreviated New Drug Applications (ANDAs) to the US FDA, ensuring compliance with regulatory requirements. 2) Scope This SOP…

Stability Studies SOP