Tag: WHO Stability Guidelines

SOP for Conducting Stability Testing for Temperature-Sensitive Biologics in Compliance with Regulatory Guidelines

SOP for Conducting Stability Testing for Temperature-Sensitive Biologics in Compliance with Regulatory Guidelines Procedure for Stability Testing of Temperature-Sensitive Biologics 1) Purpose The purpose of this SOP is to provide a structured approach for conducting stability testing of temperature-sensitive biologics in compliance with global regulatory guidelines. This ensures that biologics remain stable and effective under…

Stability Studies SOP

SOP for Implementing Stability Testing for Large Molecule Drugs under FDA Guidelines

SOP for Implementing Stability Testing for Large Molecule Drugs under FDA Guidelines Procedure for Stability Testing of Large Molecule Drugs According to FDA Guidelines 1) Purpose The purpose of this SOP is to define a procedure for conducting stability testing on large molecule drugs (biologics) in accordance with US FDA guidelines. This ensures that such…

Stability Studies SOP

Stability Sample Retesting Guidelines for OOS Results

🔎 Understanding the Need for Retesting in Stability Studies Stability studies are critical to determining the shelf life and storage conditions of drug products. Occasionally, test results fall outside the approved specification—termed as OOS (Out-of-Specification). When such results are observed, retesting the same sample is permitted only under strict regulatory justification. This article focuses on…

Deviation and OOS Handling in Stability Testing, Pharmaceutical Quality and Practices

SOP for Conducting Stability Studies in Compliance with Brazilian Health Regulatory Agency (ANVISA) Guidelines

SOP for Conducting Stability Studies in Compliance with Brazilian Health Regulatory Agency (ANVISA) Guidelines Procedure for Stability Testing According to ANVISA Guidelines 1) Purpose The purpose of this SOP is to establish the procedure for conducting stability studies in compliance with the guidelines of the Brazilian Health Regulatory Agency (ANVISA). This ensures that drug products…

Stability Studies SOP

Writing Effective CAPAs for Temperature Excursions in Stability Chambers

Temperature excursions in stability chambers are among the most frequently reported deviations in pharmaceutical stability programs. If not addressed effectively, these incidents can compromise drug product quality, violate GMP norms, and result in regulatory actions. This tutorial outlines how to write effective CAPAs (Corrective and Preventive Actions) in response to temperature excursions, ensuring a robust…

Handling Deviations and CAPA in Stability Reports, Protocols and Reports

SOP for Applying ICH Q1A(R2) for Stability Testing of Drug-Device Combination Products

SOP for Applying ICH Q1A(R2) for Stability Testing of Drug-Device Combination Products Procedure for Stability Testing of Drug-Device Combination Products Following ICH Q1A(R2) Guidelines 1) Purpose The purpose of this SOP is to define the procedures for conducting stability testing on drug-device combination products in accordance with the International Council for Harmonisation (ICH) Q1A(R2) guidelines….

Stability Studies SOP

SOP for Addressing Stability Testing Requirements for Investigational New Drug (IND) Applications

SOP for Addressing Stability Testing Requirements for Investigational New Drug (IND) Applications Procedure for Stability Testing for IND Applications 1) Purpose The purpose of this SOP is to define the procedures for conducting stability studies required for Investigational New Drug (IND) applications. This SOP ensures that stability data is generated in compliance with regulatory guidelines…

Stability Studies SOP

SOP for Conducting Stability Studies for Topical Products in Compliance with US FDA and EMA Guidelines

SOP for Conducting Stability Studies for Topical Products in Compliance with US FDA and EMA Guidelines Procedure for Stability Testing of Topical Products According to US FDA and EMA Guidelines 1) Purpose The purpose of this SOP is to establish a standardized procedure for conducting stability studies on topical drug products in compliance with the…

Stability Studies SOP

SOP for Implementing ICH Q9 for Risk Management in Stability Testing

SOP for Implementing ICH Q9 for Risk Management in Stability Testing Procedure for Risk Management in Stability Testing According to ICH Q9 1) Purpose This SOP outlines the procedures for implementing risk management principles based on the ICH Q9 guidelines for stability testing. The goal is to identify, assess, and control risks that may impact…

Stability Studies SOP

SOP for Conducting Stability Studies for Fixed-Dose Combination Products under Regulatory Guidelines

SOP for Conducting Stability Studies for Fixed-Dose Combination Products under Regulatory Guidelines Procedure for Stability Testing of Fixed-Dose Combination Products 1) Purpose The purpose of this SOP is to define the procedures for conducting stability studies on fixed-dose combination (FDC) products to comply with regulatory guidelines. This SOP ensures that stability data for FDC products…

Stability Studies SOP