From 1st-10th April, our Senior Associate Maxim Bunimovich will be taking part in the ‘New Clinical Stars’ project, hosted by The QARP in Russia.
This week, our Quality Management team issued a simple yet effective Quality Principles and PDCA infographic detailing the seven Quality Management principles: the 9001 approach; the PDCA Cycle, and how the clauses of the standard align to the PDCA cycle; and, of course, links to continual improvement, monitoring, and driving the effectiveness of the QMS. Click here to download.
FDA issues Inspection Statistics for 2020
The U.S. Food and Drug Administration (FDA) has issued its Bioresearch Monitoring (BIMO) statistics for 2020. The statistics include analysis of the types and number of inspections conducted, and the most common non-compliances seen for each type of inspection.
MHRA – GCP Stakeholder Engagement Meeting March 2021
On 23rd March 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) issued minutes and slides from the GCP Stakeholder Engagement Meeting (StEM), held on the 15th of March.
AstraZeneca issues update on vaccine efficacy
On 25th March 2021, AstraZeneca published updated COVID-19 vaccine efficacy results for its US trial following reports that outdated information was being used. The updated statement indicated the AstraZeneca vaccine as 76% effective in preventing symptomatic COVID-19, slightly lower than 79% figure released on 22nd March 2021.
EMA announces increase in vaccine manufacturing capacity and supply of COVID-19 vaccines
On 26th March 2021, the EMA’s Human Medicines Committee (CHMP) announced it has implemented several recommendations that will increase the manufacturing capacity and supply of COVID-19 vaccines in the EU. This includes a new manufacturing site for AstraZeneca’s vaccine; a new manufacturing site and more flexible storage conditions for BioNTech/Pfizer’s vaccine; and a new manufacturing site and scaled-up processes for Moderna’s vaccine.
MHRA Inspectors Blog – Inspecting During a Pandemic
On 26th March 2021, the MHRA issued a blog describing the innovative approaches developed to maintain the inspection programme throughout the pandemic. Moving forward, inspectors will continue to innovate, with their focus currently on incorporating ‘visual technologies’, which will enable a level of ‘eyes on site’.
FDA issues update on its ongoing COVID-19 response effort
On 30th March 2021, the FDA announced more actions taken in its ongoing response effort to the COVID-19 pandemic. Updates include the approval of an abbreviated new drug application (ANDA) for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
FDA publishes product specific guidelines
The FDA has published a new batch of product-specific guidances (PSGs) for Generic Drug Development.
Issue Number: WN0004
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