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Since 25 August 2023, the revised European Union guidelines for Good Manufacturing Practice (EU GMP) Annex 1 has imposed requirements to implement a Contamination Control Strategy (CCS) across the facilities of finished drug product manufacturers, to ensure higher quality and sterility of medicinal products for human and veterinary use.
The Standing Committee of the National People’s Congress in China passed the revised Drug Administration Law (Revised Law) on 26-Aug-19. Effective 1-Dec-19, it is the first overhaul since 2001.The Revised Law addresses the major issues in the pharmaceutical industry, demonstrating the government’s efforts in strengthening supervision to ensure drug safety.
To reduce and detect particulate matter is a shared responsibility between Container Closure component suppliers and the pharmaceutical industry. Keeping the patient´s safety in mind, lively discussions about particle inspection were held in the panel session at the PDA Conference on Freeze Drying Technologies.
In 2012, the pharmaceutical industry will face many challenges, not the least of which will be the need to adjust research and development and business models to respond to the growing importance of specialty pharmaceuticals. Such products include sensitive biopharmaceuticals and the growth of biosimilars. Efficiency in manufacturing and the ability to meet critical compliance standards are a must to compete and meet today’s challenges.
Join West’s Diane Paskiet at the 2013 PDA/FDA Container Closure Components and Systems Workshop:<em>Protecting Parenteral Drugs and Biologics Using Suitable Container Closure Systems,</em> on May 14-15, 2013, at the Hyatt Regency Bethesda in Bethesda, Maryland.
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