Pharmacovigilance Drug safety or pharmacovigilance is an important and growing field in the pharmaceutical industry, which is strongly influenced by Swiss, European and international laws and regulations. According to HMG Art. 59, the authorization holder, manufacturer or distributor of ready-to-use remedies must provide for a PV reporting system. This includes, inter alia, the name of [...]
Medical products play a key role on the healthcare sector; their range reaches from a simple plaster up to a complex life-support device. This diversity of products combined with great innovation in the branch leads, among other things, to ever-increasing regulation and more complex requirements for manufacturers: the requirements of the Quality Management System (QMS) [...]
The Qualified Person (QP) plays an important role in the pharmaceutical production and distribution of medicinal products. He or she closely supervises the company in all matters related to the handling of pharmaceuticals to ensure their secure handling. The Qualified Person is responsible for the production and distribution according to the valid specifications and the [...]
As part of the quality assurance in the pharmaceutical industry, Good Distribution Practice (GDP), should ensure that pharmaceuticals are always adequately transported and stored, in order to maintain the products’ quality and effectiveness and to always guarantee patient safety. Global supply chains are becoming more complex and comprehensive. Accordingly, the demands placed on manufacturers and [...]
Good Manufacturing Practice GMP is based on laws, guidelines and internationally harmonized standards to assure the quality of all production processes, premises and facilities in the production of pharmaceuticals, ingredients, medical products and cosmetics. GMP’s primary objective is to ensure the quality, efficacy and safety of the products and thereby the safety of consumers. The [...]
