Search results for good manufacturing practice

The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies

Author byline as per print journal: Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4, Tetsuya Tanimoto5, MD; Mihajlo Jakovljevic6,7,8, MD, PhD Abstract: This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It […]

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Trends in Saudi FDA drug approvals and GMP inspections: an observational study

Author byline as per print journal: Ali M Alhomaidan, PhD; Mohammed Abdulaziz Alageel, MSc; Turki Abdulaziz Alrafie, MSc; Hassan Mohammed Alqarni, MSc; Ibraheem Yahya Khbrani, MSc; Dalal J Alkhamis, MSc; Mohammed F Alkhalifah, MSc; Abdualmajeed S bin Jumaiah, MSc; Mohammed A Dahhas, PhD Abstract: The Saudi Food and Drug Authority’s (SFDA) pharmaceutical products approval and […]

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Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Christine Koh, BSc (Pharm) (Hon); Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD Abstract: Cell, tissue and gene therapy products (CTGTPs) are therapeutic products intended for use in humans for prophylactic, diagnostic, curative, palliative or diagnostic purposes. Generally, they are […]

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Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD Abstract: Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells. […]

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