Regulatory/GMP Compliance

Jun 21, 2018
By BioPharm International Editors
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
Jun 20, 2018
Legislators have requested that FDA do more to prevent drug shortages.
Jun 15, 2018
BioPharm International
Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.
Jun 15, 2018
BioPharm International
An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.
Jun 08, 2018
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
Jun 07, 2018
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
Jun 06, 2018
By BioPharm International Editors
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
Jun 04, 2018
By BioPharm International Editors
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.
Jun 01, 2018
BioPharm International
FDA and Congress seek to limit the production and distribution of pain medicines.
Jun 01, 2018
BioPharm International
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
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