Tag: Pharmaceutical Shelf Life

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

Regulatory Expectations for Accelerated Stability Testing Submissions

Regulatory Expectations for Accelerated Stability Testing Submissions Submitting Accelerated Stability Testing Data: Regulatory Expectations Explained Accelerated stability testing is a vital component of pharmaceutical submissions, especially during early-phase development, technology transfers, and shelf life justifications. Understanding what global regulatory bodies expect in accelerated stability submissions can ensure faster approvals, fewer queries, and greater confidence in…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Real-Time Stability Testing Case Study: Oral Solid Dosage Forms

Real-Time Stability Testing Case Study: Oral Solid Dosage Forms Case Study: Implementing Real-Time Stability Testing for Oral Solid Dosage Forms Real-time stability testing is a regulatory requirement and quality assurance cornerstone in the pharmaceutical industry. This expert case study explores the end-to-end implementation of real-time stability testing for oral solid dosage forms (tablets and capsules),…

Real-Time and Accelerated Stability Studies, Stability Testing Types

ICH Guidelines for Accelerated Stability Testing

ICH Guidelines for Accelerated Stability Testing Implementing ICH-Compliant Accelerated Stability Testing Protocols Accelerated stability testing is a crucial component of pharmaceutical development, enabling faster assessment of a product’s stability under stressed conditions. This tutorial explains how to design and execute accelerated stability testing protocols aligned with ICH guidelines, helping pharma professionals estimate shelf life and…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Shelf Life and Expiry in Pharmaceuticals: Principles, Testing, and Compliance

Shelf Life and Expiry in Pharmaceuticals: Principles, Testing, and Compliance Understanding Shelf Life and Expiry in Pharmaceutical Products Introduction Shelf life and expiry dates are fundamental to pharmaceutical product quality and patient safety. These parameters determine how long a drug can be stored and used while maintaining its intended potency, safety, and efficacy. The assignment…

Shelf Life and Expiry

Real-Time and Accelerated Stability Studies: Best Practices for Pharma

Real-Time and Accelerated Stability Studies, Stability Testing Types

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

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

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