Quality System Development and Maintenance
Development
Pharmaceutical companies that distribute medicinal products in Switzerland require a pharmaceutical establishment licence (PEL). Swissmedic issues this licence based on a successful inspection of the quality system or other evaluation. We prepare the quality system documentation, either as a “stand alone” or integrated in your already existing international structures and assist you during the inspection to meet Swissmedic standards and pass the inspection.
- Write-up of the basic SOPs or adaptation of your already existing ones
- Write-up the required quality agreements or adapt your already existing ones
- Conduct training
- Preparation and execution of administrative steps such as communications with health authorities and inspectors
Maintenance
Swissmedic and four regional cantonal inspectorates carry out regular inspections to maintain your pharmaceutical establishment licence. They examine different aspects of the quality performance. We prepare the documentation demonstrating your performance and assist you during the inspection to meet Swissmedic standards and pass the inspection.
- Review SOP and revise if indicated
- Review and revise mandatory quality agreements
- Conduct of internal and external audits
- Services of a local responsible person (qualified person and qualified person for pharmacovigilance)
Target BioScience AG has a year’s long experience in different types of company’s settings and can provide services for small size and complex company’s structures. Detailed information is provided upon request.