Pharma Stability: Insights, Guidelines, and Expertise
SOP for Ensuring Compliance with Global Stability Testing Requirements (US FDA, EMA, WHO) Standard Operating Procedure for Global Stability Testing Compliance 1) Purpose The purpose of this SOP is to establish a systematic approach to ensure compliance with global stability testing requirements as set by major regulatory authorities such as the US Food and Drug…
SOP for Designing Stability Studies for Drug Products with Extended Shelf Life under Regulatory Guidelines Guidelines for Stability Testing of Drug Products with Extended Shelf Life as per Regulatory Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for designing stability studies for drug products with extended shelf life…
Low-solubility active pharmaceutical ingredients (APIs) present complex formulation and stability challenges, often due to incomplete dissolution, erratic degradation kinetics, and formulation variability. In this case study, we walk through the practical application of ICH Q1E statistical principles to estimate shelf life for a poorly soluble drug, highlighting lessons learned and pitfalls avoided. 🔬 Drug Profile…
Read More “Case Study: Shelf Life Estimation for Low-Solubility Drug” »
SOP for Conducting Stability Testing for Advanced Therapy Medicinal Products (ATMPs) per EMA Guidelines Guidelines for Stability Testing of ATMPs as per EMA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for Advanced Therapy Medicinal Products (ATMPs) in accordance with European Medicines Agency (EMA)…
SOP for Implementing Stability Testing for Drugs with Novel Delivery Systems under US FDA Guidelines Guidelines for Stability Testing of Drugs with Novel Delivery Systems as per US FDA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for drugs with novel delivery systems in…
SOP for Conducting Stability Studies for Drug Products in Compliance with Indian Regulatory Requirements (CDSCO) Guidelines for Stability Testing of Drug Products as per Indian Regulatory Requirements (CDSCO) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability studies for drug products in accordance with the Central Drugs…
SOP for Applying ICH Guidelines to Stability Testing for Radiopharmaceuticals Guidelines for Stability Testing of Radiopharmaceuticals as per ICH Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing of radiopharmaceuticals in accordance with the ICH guidelines. This SOP ensures that stability data supports the quality,…
Read More “SOP for Applying ICH Guidelines to Stability Testing for Radiopharmaceuticals” »
Stability testing is the backbone of pharmaceutical product lifecycle management. It not only determines a product’s shelf life but also supports labeling claims and global registration. However, identifying significant changes during stability testing is a critical component of compliance—missed or misclassified changes can result in regulatory delays or rejection. This guide walks pharma professionals through…
Read More “Identifying Significant Changes During Stability Testing: A Compliance Guide” »
In the pharmaceutical industry, Quality by Design (QbD) demands that every element of drug development — including stability protocols — be derived from scientifically justified foundations. One of the most critical links in this chain is between the Quality Target Product Profile (QTPP) and the selection of appropriate storage conditions for stability testing. This tutorial…
Read More “Linking QTPP to Storage Conditions in Stability Protocols” »
SOP for Implementing Stability Testing for Cell Therapy Products under ICH Q5A Guidelines for Stability Testing of Cell Therapy Products as per ICH Q5A 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for cell therapy products in accordance with the ICH Q5A guidelines. This SOP…
Read More “SOP for Implementing Stability Testing for Cell Therapy Products under ICH Q5A” »