The assurance of safety and innocuousness of medicinal products and cosmetics is a key GMP demand. To this end, the prevention of product contamination, cross-contamination and microbiological contamination is of paramount importance. This requires an encompassing and effective system for Hygiene Management.
From several years of experience, working with various companies, we are well aware not only of the needs of mid-size businesses but also of larger corporations. This is what allows us to provide differentiated solutions to differing company circumstances.
Our services in this area comprise:
- Gap-analysis to identify weak-points and improvement potential
- Concept design and optimization of flow of personnel and material flow
- Development of hygiene concepts (including zoning concepts and lock concepts) for production areas (sterile and non-sterile products)
- Preparation and optimization of hygiene plans
- Compilation of checklists and work instructions for all areas of Hygiene Management
- Concept preparation and administration of microbiological monitoring
- Root cause analysis of hygiene management incidents such as OOS results in microbiological monitoring
- Advising support in choosing cleaning agents and desinfectants for various applications
- Effective interactive training of production staff and cleaning personnel in matters of hygiene