BSE/TSE Risks Associated with Active Pharmaceutical Ingredients and Starting Materials: The
Situation in Europe and the Global Implications for Healthcare Manufacturers | PDA Journal of …

The risk of infection with transmissible spongiform encephalopathy (TSE) from the use of
animal-derived substances in drug manufacturing was assessed [Swissmedic. TSE …

The core of the scientific advisory system of the European Com-mission (EC) comprises nine
scientific committees including a Scientific Steering Committee (SSC) which cover the …

The pharmaceutical industry is one of the most regulated industries in Switzerland. Though
the concept of good manufacturing practises (GMP) was implemented for chemical …

Food contact materials (FCMs) are materials and articles intended to be placed in direct or
indirect contact with foodstuffs, or which can reasonably be expected to come into contact …

An industry workgroup comprised of toxicologists and manufacturing equipment cleaning
subject matter experts was formed to examine the European Medicines Agency (EMA) …

Pharmaceuticals and personal care products (PPCPs) encompass a large class of chemical
contaminants that can originate from human usage and excretions and veterinary …

According to the modern requirements of the European Union's Good Manufacturing
Practice for Medicinal Products, a manufacturing authorization holder should guarantee the …

During storage and distribution of a packaged drug product, chemical substances present in
or on the packaging may leach into the drug product, potentially adversely affecting the drug …

Vaccination is an essential tool to protect humans from many infectious diseases. Materials
derived from bovine tissues are used in, or during the manufacture of, most vaccines …