Excellent quality management systems (QMS) ensure that the quality of procedures and processes within your company permanently getting monitored and improved. Main purpose of a Quality Management System is a sustainable improvement in planning, executing and monitoring the quality of your production and your products.
Pharmaceutical quality management systems are able to cover all aspects of a product’s life cycle, from development to patient use. Quality assurance measures, known as “good practice”, are in place for every step along the way. These include good manufacturing practice (GMP) guidelines, which were first published by the WHO in 1968 and have ever since been amended and expanded on several occasions. The EU GMP Guidelines outline the GMP rules applicable in the European Union. There are similar EU guidelines for the distribution of medicinal products (good distribution practice, GDP) and drug safety monitoring (good pharmacovigliance practice, GVP). A company’s Qualified Person (QP), and its Qualified Person for PharmacoVigilance (QPPV), are responsible for ensuring compliance with GxP guidelines and drug safety.
zelhealth supports pharmaceutical companies and their QPs in efficiently integrating these standards into their own quality management systems, complying with GxP guidelines and proving compliance to regulatory authorities during inspection. We develop complete GxP quality management systems and provide advice on quality assurance. If required, we take responsibility for compliance with these guidelines with own QPs, QPPVs or acting as Responsible Person for Medical Device Safety (Sicherheitsbeauftragter according to the German MPG).
Our services:
- Advice on all GxP areas
- Gap analysis
- Preparation and maintenance of QM systems
- Preparation and maintenance of SOPs
- Risk management and FMEA
- Audits and inspections
- Own QP/QPPV/Responsible Person for Medical Device Safety service
