Author: digi

PIC/S Guidelines for Good Manufacturing Practices in Stability Testing

PIC/S Guidelines for Good Manufacturing Practices in Stability Testing Understanding PIC/S Guidelines for GMP in Stability Testing Introduction Stability testing is a critical component of pharmaceutical development and manufacturing, ensuring that products maintain their quality, safety, and efficacy throughout their lifecycle. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a significant role in harmonizing Good Manufacturing…

Regulatory Guidelines

SOP for Conducting Stability Studies for Intrathecal Drugs

SOP for Conducting Stability Studies for Intrathecal Drugs Guidelines for Stability Testing of Intrathecal Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on intrathecal drugs. Stability testing is essential to ensure that these drugs maintain their safety, efficacy, and quality when stored under various conditions…

Stability Studies SOP

The Impact of Packaging on Stability Testing Outcomes

The Impact of Packaging on Stability Testing Outcomes Expert Guide to the Role of Packaging in Stability Testing Introduction to Packaging in Stability Testing Packaging plays a critical role in maintaining the stability of pharmaceutical products. It protects the drug from environmental factors such as light, moisture, and oxygen, ensuring its quality, efficacy, and safety…

Types of Stability Studies

Shelf Life Testing for Controlled Substances: Regulatory Insights

Shelf Life Testing for Controlled Substances: Regulatory Insights Expert Insights on Shelf Life Testing for Controlled Substances Introduction: The Unique Challenges of Controlled Substances Controlled substances, including opioids, psychotropics, and certain cannabinoids, require stringent oversight throughout their lifecycle to ensure compliance with safety, efficacy, and regulatory standards. Conducting shelf life stability testing for these substances…

Shelf Life and Expiry Dating

Role of Packaging in Ensuring Stability for New Drug Substances

Role of Packaging in Ensuring Stability for New Drug Substances How Packaging Ensures Stability for New Drug Substances Introduction Developing new drug substances is a complex process that involves rigorous testing to ensure their safety, efficacy, and stability. Packaging plays a pivotal role in maintaining the integrity of these substances by shielding them from environmental…

Packaging - Containers - Closers

The Future of API Stability Testing: Trends and Innovations

The Future of API Stability Testing: Trends and Innovations The Future of API Stability Testing: Trends and Innovations Introduction to API Stability Testing API stability testing is a cornerstone of pharmaceutical development, ensuring that Active Pharmaceutical Ingredients (APIs) maintain their quality, efficacy, and safety throughout their lifecycle. As the pharmaceutical industry evolves, advancements in technology…

Stability Studies - API

Using Accelerated Stability Studies for Shelf Life Predictions

Using Accelerated Stability Studies for Shelf Life Predictions A Comprehensive Guide to Accelerated Stability Studies for Shelf Life Predictions Introduction: The Need for Accelerated Stability Studies Determining the shelf life of pharmaceutical products is a critical step in ensuring their safety, efficacy, and quality. While real-time stability studies are the gold standard, they require long…

Shelf Life and Expiry Dating

Managing Stability Studies for Biopharmaceuticals: A Practical Guide

Managing Stability Studies for Biopharmaceuticals: A Practical Guide A Step-by-Step Guide to Managing Stability Studies for Biopharmaceuticals Introduction to Stability Studies for Biopharmaceuticals Biopharmaceuticals, such as monoclonal antibodies, recombinant proteins, and cell-based therapies, have transformed modern medicine. However, their complex and sensitive nature presents unique challenges in stability testing. Ensuring the safety, efficacy, and quality…

Types of Stability Studies

ICH Q8 and Its Role in Pharmaceutical Development Stability Studies

ICH Q8 and Its Role in Pharmaceutical Development Stability Studies How ICH Q8 Shapes Stability Studies in Pharmaceutical Development Introduction The International Council for Harmonisation (ICH) guideline Q8: Pharmaceutical Development provides a structured framework for the systematic design, development, and optimization of pharmaceutical products. It emphasizes a science- and risk-based approach to drug formulation and…

Regulatory Guidelines

Stability Challenges in APIs for Biopharmaceutical Combination Products

Stability Challenges in APIs for Biopharmaceutical Combination Products Understanding Stability Challenges in APIs for Biopharmaceutical Combination Products Introduction to Biopharmaceutical Combination Products Biopharmaceutical combination products represent a rapidly growing segment in the pharmaceutical industry, integrating Active Pharmaceutical Ingredients (APIs) with biologics, devices, or other drug components to enhance therapeutic outcomes. However, their complex nature introduces…

Stability Studies - API