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International Collaboration and Reliance: Regulatory Panel Discussion at the 2022 ISPE Singapore Conference

ISPE

Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic. Dr Gouws indicated that many of the Covid-19 vaccine manufacturers in India had also been inspected by WHO and a similar information sharing approach had been undertaken by WHO.

FDA 97
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Evgenyi Shalaev, PhD

Blog: Ask a Student Pharmacist

197-217 SG Chou, AK Soper, S Khodadadi, JE Curtis, S Krueger, MT Cicerone, A Fitch, E Shalaev (2012). In : Lyophilized Biologics and Vaccines: Modality-Based Approaches. Current research interests include: Role of water in solid-state chemical stability of proteins and small molecules Advanced analytical methods (e.g.,

Dosage 52
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Regulatory Panel Discussion on International Collaboration and Reliance

ISPE

Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic. Dr Gouws indicated that many of the Covid-19 vaccine manufacturers in India had also been inspected by WHO and a similar information sharing approach had been undertaken by WHO.

FDA 52
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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Published May 2012. Published 2008. 5 (May 2022): 1232–1244.

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Contamination Trends & Proposed Solutions

ISPE

2 , 16 , 17 , 18 One example is the switching of tributyltin azide with sodium azide and dimethyl formamide by Zhejiang Huahai Pharmaceuticals (ZHP) in 2012 to reduce waste and to increase yield in the production of angiotensin II receptor blockers, resulting in the formation of N-nitrosodimethylamine (NDMA), a known carcinogenic impurity.