GMP’s in foreign material control

GMP’s in foreign material control Since foreign material control is a matter of grave importance to the American public, there are several Good Manufacturing Processes (GMP’s) that are in place for this industry. As defined by the FDA; GMP’s for foreign material control include facility, processing and employee practices aimed primarily at microbial control, but […]

The ICH Q 7 A–important sections

The ICH Q 7 A–important sections The ICH Q 7 A is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug. The Q 7 was arrived at by the International Conference of Harmonization […]