Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

Implementation Status and Barriers of Good Manufacturing Practice (gmp) for Chinese Patent Medicine

Background: Safety, quality and effectiveness of Chinese patent medicine (CPM) are highly relevant to the manufacturing process. However, the level of manufacturing practice (GMP) for CPM as implemented in China is less reported in literatures. Therefore, the aim of this paper was to reveal the implementation status of GMP for CPM in China, in terms of implementation principle, implementation c...

Good publication practice for pharmaceutical companies.

Guidelines on Good Publication Practice (GPP) for pharmaceutical companies are presented. The aim of the guidelines is to ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner. The guidelines cover companies' responsibility to an endeavour to publish results of all studies, companies' relations with investigators, measures to prevent...

The safety of pharmaceutical excipients.

The most important part of a medicine as far as its weight is concerned, is constituted by its excipients, which have the important functions of guaranteeing the dosage, stability and bioavailability of the active principle. The components employed as excipients must present the characteristics required by their technological function but, as with any substance administered to man, they must al...

Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation

Elemental Impurities in Pharmaceutical Excipients.

Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by ...