Tag: regulatory compliance packaging

Packaging Material Certification for Regulatory Compliance in Stability Studies

Regulatory authorities such as the USFDA, EMA, and CDSCO place great emphasis on the quality and traceability of packaging components used in pharmaceutical stability testing. Certifying packaging materials is not only a GMP requirement but a key factor in ensuring data integrity and regulatory acceptance. This article outlines the regulatory expectations, documentation requirements, and best…

Packaging and Containers, Packaging Materials Impact on Stability Testing

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