Accelerating the development and delivery of innovative and biosimilar antibodies to patients enhances quality of care and quality of life. Shortening development times also helps biotech companies efficiently deploy capital while providing their investors with a faster return on investment. This presentation outlines specific areas where KBI significantly reduces development timelines to enable faster progression into and through clinical trials for therapeutic antibodies.
GMP Compliance by Inspection is prerequisite for marketing authorization of a pharmaceutical product in Japan. GMP compliance inspection or investigations must be done not only at the time of marketing authorization application but also after marketing authorization is provided, periodical ones must be given to drug manufacturing sites. Since the establishment of PMDA in 2004, PMDA’s Office of Manufacturing/Quality and Compliance have conducted GMP compliance inspections to domestic as well as overseas manufacturing sites. Comprehensively PMDA confirmed methods and practices of quality and production control of APIs and drug products and it has contributed to supply of better quality products.
My lecture will present on PMDA’s inspection approaches, uncompliant GMP inspection cases, and the necessity for cooperation between overseas API manufacturers and MAHs in Japan
Bollore logistics, headquartered in Paris FRANCE, is a global leader in Int'l Transport & Logistics. We are operating in 102 countries with 21,000 employees. The company has enriched its expertise to become a tier-one supply chain partner and one of the Top 10 logistics company in the world with its integrated logistics network and knowledge. In line with strong corporate QHSE policy and culture, Bollore Logistics Korea has invested to Healthcare logistics in cooperation with the expertise in HQ and Regional Healthcare Management. Our investment result in CEIV Pharma Certificate & opening KGSP warehouse in Osan.
The 17th Edition of Japanese Pharmacopoeia has been published in March and enforced in April 2016. The English version will be available in September.
In the coming lecture I will explain the main revised parts of the 17th edition, such as comprehensive administration of residual solvents and public comments invitation in the PMDA’s English version website and trials for disclosure of the column information.
Regarding the latest information on the master files, I will talk about the requirement for attachment materials of the application dossier of generic prescription drugs which shall be in principle in CTD format according to the notification published in March 2016.