Biosimilar Regulatory solution center

41. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

    One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

42. What To Do When Your Regulatory Findings Need Quality Risk Management Action 10/2/2024

    More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

43. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

    Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

44. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals 9/11/2024

    The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

45. PUPSIT As Part Of A Contamination Control Strategy (CCS) 8/21/2024

    Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

46. When Should Filter Validation Be Performed? 8/21/2024

    Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

47. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

48. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

    The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

49. Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations 8/6/2024

    ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

50. DSCSA Implementation Is Progressing, But More Complexity May Be Coming 8/5/2024

    The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.