More Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian pharmaceutical Company
More EMA and FDA publish Q&A Document on their accelerated Approval Programmes
More FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products
More FDA Warning Letter: Data Integrity issues while manufacturing APIs
More FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft
More Another FDA Warning Letter for Chinese Company based on Review of Records
More EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks
More Checklist for Implementation of GDP Principles - Part 4: Documentation
More FDA Warning Letter: Observed particulates in repackaged drug components