Regulatory Guidelines

PIC/S Guidelines: Harmonizing Global Stability Testing Practices

PIC/S Guidelines: Harmonizing Global Stability Testing Practices Harmonizing Global Stability Testing Practices: The Role of PIC/S Guidelines Introduction In the pharmaceutical industry, stability testing ensures that products maintain their safety, quality, and efficacy throughout their shelf life. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a critical role in harmonizing these testing practices globally. By providing…

A Step-by-Step Guide to ICH Q1E: Evaluation of Stability Data

A Step-by-Step Guide to ICH Q1E: Evaluation of Stability Data Step-by-Step Guide to Evaluating Stability Data Using ICH Q1E Introduction Stability testing is a cornerstone of pharmaceutical development, ensuring that products maintain their quality, safety, and efficacy throughout their shelf life. While ICH Q1A(R2) provides guidelines for conducting stability studies, ICH Q1E focuses on the…

Regulatory Guidelines

What’s New in ASEAN Stability Guidelines for 2023?

What’s New in ASEAN Stability Guidelines for 2023? Exploring Updates in ASEAN Stability Guidelines for 2023 Introduction The ASEAN Stability Guidelines are a cornerstone of pharmaceutical regulation in Southeast Asia, ensuring that drug products remain safe, effective, and high-quality under the region’s unique climatic conditions. As the pharmaceutical industry evolves, so do the regulatory frameworks…

Regulatory Guidelines

Bridging Regional Differences: Comparing FDA, EMA, and ASEAN Guidelines

Bridging Regional Differences: Comparing FDA, EMA, and ASEAN Guidelines How to Navigate Regional Differences: Comparing FDA, EMA, and ASEAN Guidelines Introduction Pharmaceutical stability testing is governed by regulatory guidelines that vary across regions. While harmonized frameworks like ICH Q1A(R2) provide a foundation, regional agencies such as the FDA (United States), EMA (European Union), and ASEAN…

Regulatory Guidelines

ICH Q1B for Photostability Testing: Ensuring Drug Safety

ICH Q1B for Photostability Testing: Ensuring Drug Safety Step-by-Step Guide to ICH Q1B: Photostability Testing for Drug Safety Introduction Photostability testing is a critical aspect of pharmaceutical development, ensuring that drug products remain stable and effective when exposed to light. The ICH Q1B guideline provides a comprehensive framework for evaluating the effects of light exposure…

Regulatory Guidelines

EMA Shelf-Life Guidelines: Navigating Regulatory Challenges

EMA Shelf-Life Guidelines: Navigating Regulatory Challenges Expert Guide to EMA Shelf-Life Guidelines: Overcoming Regulatory Challenges Introduction Shelf life is a critical attribute of pharmaceutical products, ensuring their quality, safety, and efficacy over time. In the European market, the European Medicines Agency (EMA) governs shelf-life determination through stringent guidelines aligned with international standards like ICH Q1A(R2)….

Regulatory Guidelines

ASEAN Guidelines for Stability Studies in Tropical Climates

ASEAN Guidelines for Stability Studies in Tropical Climates Understanding ASEAN Guidelines for Stability Studies in Tropical Climates Introduction The ASEAN Stability Guidelines provide a tailored framework for conducting stability studies in tropical climates, addressing the unique environmental challenges of the Southeast Asian region. High temperatures and humidity levels can significantly affect the stability of pharmaceutical…

Regulatory Guidelines