The required safety of your products is guaranteed by the fulfillment of the GMP guidelines anchored in laws and regulations, for the pharmaceutical, medical device or cosmetics industry with the goal of continuous improvement of the processes.

All areas such as development, planning, introduction, maintenance and delivery of the products are included along the way.

The basis is formed by clearly defined processes, the definition of unambiguous areas of responsibility, and comprehensible documentation. The inclusion of risk management is an essential factor.

The hygiene aspect in your cleanrooms is given high priority:

• Is there an appropriate clothing concept in accordance with the cleanroom class in question?
• Is the clothing concept continuously implemented and have your employees internalized the dressing procedure?
• Is there an adequate training concept, on correct behavior in the cleanroom?
• Is the hygiene concept sufficient (selection/change of disinfectants, implementation of surface cleaning: internal/external, definition of cleaning specifications, etc.)?

We would be pleased to support you, with our portfolio of services, in being successful!

Excerpt of OUR SERVICES GENERAL

• Establishment of a QMS according to current requirements incl. creation of the QM manual
• Support for cross-site process harmonization
• Identification and elimination of QMS weaknesses and deficiencies (gap analysis)
• Critical review of existing processes and production flow - Identification and assessment of risks
• Comprehensible technical preparation of your processes and related documentation for all involved employees
• Preparation and implementation of training courses for your employees at all hierarchical levels on the subject of GMP and the quality assurance system
• Support in the execution of self-inspections and accompaniment during official inspections

Excerpt of OUR SERVICES HYGIENE

• Development and revision of hygiene concepts for your company
• Technical support for the conceptual preliminary planning of your cleanrooms and determination of requirements for all ISO / GMP classes
• Consulting for your internal cleanroom cleaning or with regard to outsourcing the service
• Preparation and implementation of cleanroom/hygiene training for your employees at all hierarchical levels including dressing procedures
• Consulting regarding the implementation of Pest Control requirements
• Preparation for service provider qualification audits