Author: digi

Selecting Representative Packaging Systems for Long-Term Stability Studies

Selecting Representative Packaging Systems for Long-Term Stability Studies Choosing the Right Packaging Systems for Long-Term Pharmaceutical Stability Studies In pharmaceutical development, the packaging system is not just a container—it’s a critical factor influencing a drug product’s stability over time. When conducting long-term stability studies, regulatory bodies require testing in packaging that accurately simulates the final…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Regulatory Requirements for Photostability Laboratory Setup

Regulatory Requirements for Photostability Laboratory Setup Setting Up a Compliant Photostability Laboratory: Regulatory and GMP Requirements Explained Photostability testing is a mandatory requirement for pharmaceutical product registration under ICH Q1B guidelines. Ensuring that a laboratory is equipped and validated for compliant light stability studies is crucial for generating reliable data, maintaining GMP alignment, and passing…

Photostability and Oxidative Stability Studies, Stability Testing Types

Handling Drug Products with Dual Light and Oxidative Sensitivity

Handling Drug Products with Dual Light and Oxidative Sensitivity Managing Pharmaceuticals Sensitive to Both Light and Oxidative Stress: Best Practices and Regulatory Insights Some pharmaceutical drug products face a dual threat: degradation upon exposure to both light and oxidative conditions. These compounds pose significant formulation and stability challenges, as degradation may occur simultaneously or synergistically…

Photostability and Oxidative Stability Studies, Stability Testing Types

Stability Challenges in Accelerated Studies for Climatic Zone IVB

Stability Challenges in Accelerated Studies for Climatic Zone IVB Addressing Stability Challenges in Accelerated Studies for Climatic Zone IVB Climatic Zone IVB — defined by long-term conditions of 30°C ± 2°C / 75% RH ± 5% — presents one of the most demanding environments for pharmaceutical stability testing. This zone, representative of hot and very…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Regulatory Trends in Biologics Stability Testing

Regulatory Trends in Biologics Stability Testing Emerging Regulatory Trends in Biologics Stability Testing: What Pharma Professionals Must Know Stability testing is a cornerstone of biologics development, providing critical insights into product integrity, shelf life, and safety. As biologics such as monoclonal antibodies, gene therapies, and cell-based products become increasingly central to modern healthcare, global regulatory…

Stability Testing for Biopharmaceuticals, Stability Testing Types

Freeze-Thaw Studies for Lyophilized Products

Freeze-Thaw Studies for Lyophilized Products Designing Freeze-Thaw Studies for Lyophilized Pharmaceutical Products Lyophilized (freeze-dried) pharmaceutical products are widely used for their enhanced stability and extended shelf-life. However, despite being dried, lyophilized formulations are not immune to the risks posed by freeze-thaw cycling. Excursions during transportation or storage can subject lyophilized vials or their reconstituted forms…

Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Validation of Photostability Testing Equipment

Validation of Photostability Testing Equipment How to Validate Photostability Testing Equipment for Regulatory Compliance Photostability testing is a regulatory requirement under ICH Q1B for evaluating the light sensitivity of pharmaceutical products. However, the reliability of photostability data hinges on the proper validation and performance qualification of the testing equipment used—typically light chambers equipped with UV…

Photostability and Oxidative Stability Studies, Stability Testing Types

Equipment and Calibration in Pharma: Ensuring GMP Compliance

Equipment and Calibration in Pharma: Ensuring GMP Compliance Ensuring GMP Compliance: A Complete Guide to Equipment and Calibration in Pharma Introduction In pharmaceutical manufacturing and quality control, equipment and its calibration play a vital role in ensuring that processes consistently yield products that meet predetermined specifications. In line with current Good Manufacturing Practices (cGMP), regulators…

Equipment and Calibration

Regulatory Justifications for Omission of Intermediate Condition Studies

Regulatory Justifications for Omission of Intermediate Condition Studies Regulatory Justifications for Omitting Intermediate Stability Studies in Pharmaceutical Development Intermediate condition studies—typically performed at 30°C ± 2°C / 65% RH ± 5%—are a critical element in pharmaceutical stability programs, especially when accelerated studies show significant change. However, there are scenarios where omitting intermediate condition testing is…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Evaluating Failed Batches in Accelerated Stability Studies

Evaluating Failed Batches in Accelerated Stability Studies Evaluation Criteria and Regulatory Response for Failed Accelerated Stability Batches Accelerated stability studies are instrumental in predicting product shelf life, but not all batches pass these rigorous tests. When a batch fails under accelerated conditions, it triggers a chain of scientific, quality, and regulatory assessments. This comprehensive guide…

Real-Time and Accelerated Stability Studies, Stability Testing Types