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The role of an integrated LIMS solution on supporting data integrity in current good manufacturing practice (cGMP) environments
europeanpharmaceuticalreview
May 21, 2019
The role of an integrated LIMS solution on supporting data integrity in current good manufacturing practice (cGMP) environments.
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BioDuro Continues Expansion with Leadership Appointments
contractpharma
May 16, 2019
Key hires to support scientific excellence, operational and financial growth plans and global business development.
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FLAMMA Opens New cGMP Kilo Lab Suite in Italy and plans construction of new R&D building
cphi-online
April 11, 2019
FLAMMA Opens New cGMP Kilo Lab Suite in Italy and plans construction of new R&D building
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FDA sends four warning letters for cGMP violations
europeanpharmaceuticalreview
April 08, 2019
The US Food and Drug Administration has posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (cGMP) regulations…
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Pall, ARTeSYN Biosolutions Expand Single-Use Technology Alliance
contractpharma
April 03, 2019
Co-development partnership aims to deliver complete solutions from clinical to commercial-scale for single-use automated bioprocessing systems
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EMA Completed Pre-Approval Inspection of cGMP DS and DP Facilities for Trogarzo™ at WuXi Biologics
en-cphi.cn
February 19, 2019
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery
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Ajinomoto, XL-protein Forge Strategic Alliance
contractpharma
December 21, 2018
Ajinomoto Bio-Pharma Services and XL-protein GmbH, a German biopharmaceutical company, have entered a Strategic Alliance, under which Ajinomoto will apply its Corynex expression system.
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Ensuring supplier and compounded drug quality
europeanpharmaceuticalreview
December 17, 2018
It is paramount that manufacturers and their suppliers ensure that the quality of compounded drugs are high, by preventing risks of contamination…
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Data integrity and compliance with drug current good manufacturing practices
europeanpharmaceuticalreview
December 14, 2018
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to…
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FDA Statement on New Efforts to Assure the Quality of Compounded Drugs
americanpharmaceuticalreview
December 12, 2018
As we continue to implement our 2018 Compounding Priorities Plan, our mission is to preserve patient access to compounded drugs to meet patients’ individual medical needs.....