Tag: shelf-life packaging risks

Top 10 Packaging Pitfalls to Avoid in EMA and FDA Stability Submissions

Packaging plays a pivotal role in pharmaceutical stability, and yet it’s often overlooked in regulatory submissions. Both the FDA and EMA have strict expectations around packaging materials, integrity, and documentation—especially in stability studies. Failing to comply can delay your approval or trigger a deficiency letter. Here are the top 10 packaging pitfalls to avoid when…

Regional Guidelines: FDA, EMA, ASEAN, TGA, Regulatory Guidelines

Packaging Material Interaction Over Long-Term Storage

Packaging Material Interaction Over Long-Term Storage Assessing Packaging Material Interaction During Long-Term Pharmaceutical Storage Pharmaceutical packaging is not just a passive container; it plays an active role in maintaining product integrity over its shelf life. During long-term storage, interactions between packaging material and the drug product can lead to degradation, contamination, or performance loss. Regulatory…

Intermediate and Long-Term Stability Testing, Stability Testing Types