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The imperative of fridge-free vaccines

European Pharmaceutical Review

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

Vaccines 111
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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. Additional requirements are described in ICH Q7.

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

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 97
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Regulatory Panel Discussion on International Collaboration and Reliance

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 52
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Common Hashimoto’s Patterns Seen in the GI-MAP Test

The Thyroid Pharmacist

A new test is being developed for MAP detection in support of a vaccine for Crohn’s disease; it has been in clinical trials, and looks very promising. Researchers found they could suppress the autoimmune response if using a vaccine or antibiotic that specifically eradicates E. 2012 Oct;4(11)1552-3]. gallinarum. [55]