Created by: Breno M. Marsona, Victor Concentinoa, Allan M. Junkerta, Mariana M. Fachia, Raquel O. Vilhenaa and Roberto PontaroloAnalytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is very […]
Created by: Ronald D. Snee, PhD, Snee Associates, LLCSnee-QbDTestMethodDevelopment-Pharm-ProcessingFeb2014Download
Created by: Chris Latoz & Kim Huynh-baCombination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA). Therefore, they require a more complex regulatory pathway and compliance with a minimum […]
Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAIAnnex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for sterile […]
Created by: Laura Pack, Senior Director, QC & Statistics, Rezolute handout_evaluation_of_stability_data_per_ich_q1e-1Download
