GMP calls for a number of perfectly interconnected quality systems, which require continuous improvement. Only prudently introduced and company fitting quality systems will be accepted by personnel in the daily work routine, and only then will those systems be capable of actually assuring quality. Furthermore, all quality systems have to be up-to-date in order to be accepted during authority inspections.
In our work, we constantly engage in recent developments of international regulations and their interpretation. This always keeps our compliance expertise up-to-date. Solid know-how and several years of experience in quality assurance of medicinal products, acquired from consulting projects in companies of various sizes and structures – this is how we make sure that you will have a tailor-made and effective quality assurance system that can confidently stand, through authority inspections and customer audits. We offer our support against the background of EU GMP requirements, the special context of Switzerland, and when it comes to US cGMP.
Our services comprise:
- Mock auditing for identification of quality assurance deficiencies and weak points
- Set-up and optimization of quality assurance processes (for example change and CAPA management)
- Preparing new SOPs, harmonization and optimization of existing SOPs as well as consulting and support in SOP implementation
- Preparation for inspections, behavioral inspection training and escorting during authority inspections and customer audits
- In-house GMP seminars and trainings for lasting change towards GMP compliance