Magnesium stearate is a white, water-insoluble powder with formula Mg(C18H35O2)2. It contains two stearate anions and one magnesium cation. Produced by reaction of sodium stearate with magnesium salts or magnesium oxide
Volume 4 contains guidance on GMP principles for medicinal products. Replaced Directive 91/356/EC for investigational medicinal products. Replaced Directive 2003/94/EC for human medicinal products. Replaced Directive 2001/83/EC for human medicinal products
Machine uses horizontal pistons to artificially chew gum at 60 chews/minute. Dissolution medium is 20 ml phosphate buffer pH 6.0 R2 at 37°C. Horizontal pistons rotate 25mm apart, vertical piston moves 22mm
Product reviews should be conducted annually, even without manufacturing. Metal detection is recommended for processes prone to metal fragments. Multiple batch numbers on packaging are generally discouraged. Supply chain traceability must be maintained for each active substance
Guideline covers viral safety evaluation of biotechnology products derived from cell lines. Applies to recombinant DNA technologies and certain genetically engineered viral vectors. Excludes non-conventional transmissible agents like prions
All EU-market medicines manufacturers must comply with GMP. GMP ensures consistent quality and appropriate use of medicines. Manufacturers must register with national competent authorities