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Global regulatory authorities COVID-19 policy and regulations meeting
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
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Good Manufacturing Practice (GMP)
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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
webinar
Accelerated development of first-in-human (FIH) programmes. Lonza’s SimpliFiH® Solutions
2 June 2020 | By Lonza
In this webinar, Lonza will present its approach to its FiH (first-in-human use) drug substance and technology-enabled drug product development programme, designed specifically to provide customers with a standardised and rapid, phase-appropriate early clinical supply programme (SimpliFiH®).
Whitepapers/App Notes/Posters
Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon, and conductivity data
Cleaning validation is an important element to cGMP manufacturing to ensure purity, quality, and potency of drug product.
Whitepapers/App Notes/Posters
Whitepaper: Rapid sterility testing: a new solution for short shelf life products
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
video
On-demand webinar: Microbiological control in a pharmaceutical manufacturing environment
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
Whitepapers/App Notes/Posters
Whitepaper: Establishing the proper alcohol/water proporation for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (Ethanol/water proportion) on the levels of Extractables.
video
On-demand webinar: ICH stability testing and method development
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
news
Active air sampler market to value $130.7 million by 2026
The active air sampler market, led by Asia-Pacific, Europe and US, is expected to grow from its current value of $92 million at a CAGR of 5.1 percent.
article
COVID-19: regulatory implications for the UK and European life sciences industry
Marie Manley and co-authors from Sidley Austin explain the updates to regulations in the EU and UK in light of the COVID-19 coronavirus pandemic.
article
How does pharma contribute to medicinal contaminants in water?
Pharmaceutical manufacturing can lead to the contamination of water ways and supply. Here, the ultimate effects from pharma’s role in environmental pollution is examined.
news
Indian drug manufacturing facility issued FDA warning letter
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
article
Exploring data integrity guideline changes moving into 2020
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
news
FDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
news
India to hold pharma companies responsible for drug quality after reforms
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.