Endotoxins are heat – stable lipopolysaccharides from Gram-negative bacteria and are potential contaminants that can be introduced during the manufacturing of pharmaceutical products, including vaccines.
The presence of rouging
in high purity water
distribution system is
stated as a troubleshooting
well known but definitely
diffcult to explain.
Typical pharmaceutical quality teams that work with regulations that are compliant to Good Manufacturing Practice (cGMP), are responsible for demonstrating control over all plant systems and processes.
Paris, July 31, 2020 (AFP) – Pharma giants Sanofi and GSK are to receive up to $2.1 billion from the US government for the development of a COVID-19 vaccine, the companies said Friday, as the world continues to be ravaged by the coronavirus epidemic.
Regulatory requirements for cleanrooms classification and monitoring are detailed by EU GMP (Annex 1) or the FDA cGMP Guidance for industry, USP<1116>(1), ISO 14644 & 14698 and PDA – TR N°13.
FPS is an Italian company specialized in the design and manufacture of containment & isolation systems and micronization solutions for the handling and production of active and sterile pharmaceutical ingredients; it is mainly addressed to pharmaceutical, chemical and cosmetic companies all over the world.
Marcy l’Étoile, France, June 16, 2020 (AFP) – French President Emmanuel Macron announced Tuesday a series of measures to boost medical research, development and production on home soil to avoid the country’s dependence on foreign suppliers in future health crises.
Physitek Devices provides analytical solutions for laboratories. Handheld and/or compact, these solutions allow to increase productivity, improve quality and identify potential risks. An offer dedicated to the pharmaceutical, cosmetics…
Strategiqual is a leading consultancy organization highly skilled for drugs, medical devices and cosmetics projects. We provide companies with a full range of innovative and customized services.
Paris, May 25, 2020 (AFP) – French pharmaceutical giant Sanofi on Monday said it planned to divest its stake in US biotech firm Regeneron which is valued at around $13 billion.
