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.
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®).
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.
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.
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
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.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
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.
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.
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.
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
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.
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.