Author: digi

Outsourcing Stability Testing to Emerging Markets: Opportunities and Compliance

Outsourcing Stability Testing to Emerging Markets: Opportunities and Compliance Strategic Outsourcing of Stability Testing to Emerging Markets: Regulatory and Operational Insights Introduction Pharmaceutical companies are increasingly outsourcing stability testing activities to Contract Research Organizations (CROs) located in emerging markets such as India, Brazil, China, South Africa, and Southeast Asia. These regions offer cost-effective infrastructure, expanding…

Outsourcing Stability Testing to Emerging Markets, Stability Studies in Emerging Markets

Data Compilation and Reporting in Intermediate and Long-Term Stability Studies

Data Compilation and Reporting in Intermediate and Long-Term Stability Studies Effective Data Compilation and Reporting in Intermediate and Long-Term Stability Studies Accurate compilation and reporting of stability data is crucial for regulatory success in pharmaceutical development. Intermediate and long-term stability studies generate extensive datasets across multiple batches, time points, and storage conditions. Regulators expect these…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Selecting Primary Batches for Real-Time Stability Testing

Selecting Primary Batches for Real-Time Stability Testing Guidelines for Selecting Primary Batches in Real-Time Stability Testing Accurate selection of primary batches is the cornerstone of a well-structured real-time stability program. Regulatory authorities such as ICH, FDA, EMA, and WHO mandate that stability studies reflect the manufacturing variability of the product, ensuring that the assigned shelf…

Real-Time and Accelerated Stability Studies, Stability Testing Types

SOP for Conducting Stability Studies for Biologics Following FDA Guidelines

SOP for Conducting Stability Studies for Biologics Following FDA Guidelines Guidelines for Stability Testing of Biologics as per FDA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting stability studies for biological drug substances and products in accordance with the US FDA guidelines. This SOP aims…

Stability Studies SOP

Case Study: Photostability Challenges in Soft Gelatin Capsules

Case Study: Photostability Challenges in Soft Gelatin Capsules Photostability Challenges in Soft Gelatin Capsules: A Formulation Case Study Soft gelatin capsules (softgels) are widely used for oral delivery of lipophilic drugs and supplements due to their ease of administration and effective bioavailability. However, these dosage forms are also among the most vulnerable to photodegradation. Both…

Photostability and Oxidative Stability Studies, Stability Testing Types

Role of Packaging Color and Opacity in Light Protection

Role of Packaging Color and Opacity in Light Protection How Packaging Color and Opacity Enhance Light Protection in Drug Products Photostability is a critical aspect of pharmaceutical product development, particularly for light-sensitive compounds that degrade upon exposure to UV or visible light. An often underestimated factor in controlling photodegradation is the packaging system—specifically, the color…

Photostability and Oxidative Stability Studies, Stability Testing Types

Stability Considerations for Liquid and Injectable Drugs

Stability Considerations for Liquid and Injectable Drugs Stability Considerations for Liquid and Injectable Drugs Introduction Liquid and injectable pharmaceutical products—whether sterile solutions, emulsions, or reconstituted powders—require rigorous stability assessment due to their complex physicochemical characteristics and heightened sensitivity to environmental and container-related factors. Unlike solid dosage forms, these products often demand specialized protocols to evaluate…

Stability Considerations for Liquid and Injectable Drugs, Stability Studies for Specific Dosage Forms

Cost-Effective Strategies for Real-Time Stability Testing

Cost-Effective Strategies for Real-Time Stability Testing Cost-Effective Strategies to Optimize Real-Time Stability Testing Real-time stability testing is a regulatory necessity in pharmaceutical development and post-approval lifecycle management. However, it can also be resource-intensive, requiring controlled storage, analytical testing, manpower, and documentation. With increasing global demand for efficiency, pharma companies are adopting strategic, cost-effective approaches that…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Freeze-Thaw Qualification of Vaccine Products

Freeze-Thaw Qualification of Vaccine Products Comprehensive Guide to Freeze-Thaw Qualification of Vaccine Products Vaccines are among the most temperature-sensitive pharmaceutical products, and even brief exposure to freezing temperatures can compromise their efficacy. Freeze-thaw qualification of vaccine products is a critical aspect of stability testing designed to assess their tolerance to unintentional cold chain excursions. This…

Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Photostability Protocol Design for Tropical Markets

Photostability Protocol Design for Tropical Markets Developing Effective Photostability Protocols for Pharmaceutical Products in Tropical Markets Pharmaceutical products destined for tropical markets face heightened environmental stress—especially from intense sunlight and high humidity. Designing a robust photostability protocol that reflects the unique degradation risks in these markets is crucial for ensuring product safety, maintaining shelf life,…

Photostability and Oxidative Stability Studies, Stability Testing Types