The new EU GMP Annex 1 has been adopted in August 2022. It will enter into force on 25 August 2023. Until then, companies have the opportunity to make the necessary internal adjustments to comply.

EU GMP Annex 1 has become much more comprehensive, including hygiene requirements.

Based on EU GMP Annex 1, processes related to contamination control must be considered in detail. Consideration of issues such as disinfection/cleaning, equipment and personnel are becoming increasingly important in CCS.

We are happy to help you implement the requirements, find the optimum solution for you and support you with our special expertise in the field of QMS and Hygienic !

HYGIENIC SERVICES

• Development and revision of hygiene concepts for your company
• Professional support for the pre-planning of your cleanrooms and determination of requirements for all ISO / GMP classes
• Advice on your in-house cleanroom cleaning or outsourcing the service
• Preparation and delivery of cleanroom/hygiene training for your staff at all levels, including gowning procedures
• Advice on the implementation of pest control requirements
• Preparation for service provider qualification audits

For more services related to the implementation of a Quality Management System, etc., see QMS and Hygienic.