Tag: trending stability data

How to Investigate Deviations in Stability Testing Programs

Deviations in stability testing programs can compromise data integrity, trigger regulatory non-compliance, and disrupt product release timelines. To maintain a compliant and effective stability program, pharmaceutical companies must have robust procedures to detect, investigate, and resolve deviations. 🔎 What Constitutes a Deviation in Stability Testing? In the context of stability programs, a deviation is any…

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

How to Reassess Risk Profiles During Product Lifecycle

As pharmaceutical products move from development to commercial distribution, their associated risk profiles evolve. Regulatory guidelines such as ICH Q9 and Q12 stress the importance of continuous risk reassessment across the product lifecycle. For stability programs, this means reevaluating earlier assumptions about degradation pathways, storage conditions, and shelf life based on emerging data and real-world…

Pharmaceutical Quality and Practices, Risk-Based Approaches to Stability Testing

Top 10 Considerations for Global Stability Study Design

Designing a pharmaceutical stability study that meets the expectations of global regulatory agencies like USFDA, EMA, WHO, and CDSCO can be challenging. From climatic zone requirements to documentation formatting, a well-structured study is key to gaining worldwide approval. This listicle breaks down the top 10 essential considerations for planning and executing a global stability strategy…

Global Harmonization of Stability Testing Regulations, Regulatory Guidelines

Lifecycle Approach to Global Stability Testing Compliance

Pharmaceutical stability testing is not a one-time activity restricted to pre-approval stages. Instead, it follows a comprehensive lifecycle approach—extending from early development through post-approval surveillance—to ensure consistent product quality over time. This regulatory-focused article explores how companies can align their global stability testing efforts with lifecycle principles, complying with agencies such as USFDA, EMA, WHO,…

Global Harmonization of Stability Testing Regulations, Regulatory Guidelines