Mechanical dry sieving requires 5-minute agitation with 0.1g-tare sieves. Air-entrainment methods use moving air current for single-sieve analysis. Total loss must not exceed 5% of original sample mass
BPCRS are primary standards established using absolute methods. BPCRS should only be used for chemical analysis, not for food or animals. All orders must be placed through BP Website
ICH Q9 focuses on science-based and risk-based quality approaches. Quality risk evaluation should link to patient protection. Quality Risk Management process should match risk level
Mechanical dry sieving requires 5-minute agitation with 5% mass loss limit. Air-jet sieving uses single sieve at a time with standardised air jet. Sonic-sifter method uses oscillating air column for powders and granules. Particle size distribution must be normal for good reproducibility
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