The required safety of your products is guaranteed by compliance with the GMP guidelines enshrined in laws and regulations, whether for the pharmaceutical, medical device or cosmetics industry, with the aim of continuously improving processes.

All areas such as development, planning, introduction, maintenance and delivery of the products are included in this process.

This is based on clearly defined processes, the definition of clear areas of responsibility and comprehensible documentation. The inclusion of risk management is a key factor here.

The hygiene aspect in your cleanrooms is a 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 for correct behavior in the cleanroom, among other things?
• Is the hygiene concept sufficient (selection/change of disinfectants, implementation of surface cleaning: internal/external, definition of cleaning specifications, etc.)?

We are happy to support you in being successful with our portfolio of services!

Extract from OUR SERVICES GENERAL

• Development of a QMS in accordance with current requirements, including creation of the QM manual
• Support for cross-location process harmonization
• Identification and elimination of QMS weaknesses and deficiencies (gap analysis)
• Critical review of existing processes and the production process - Identification and assessment of risks
• Comprehensible technical preparation of your processes and associated documentation for all employees involved
• Creation and implementation of training courses for your employees at all hierarchical levels on the subject of GMP and quality assurance systems
• Support in carrying out self-inspections and assistance with official inspections

Excerpt from OUR HYGIENE SERVICES

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