The new EU GMP Annex 1 was adopted in August 2022. It will come into force on August 25, 2023. Until this date, companies have the opportunity to make the necessary internal adjustments to meet the requirements.

EU GMP Annex 1 has become much more comprehensive, also with regard to hygiene requirements.

On the basis of EU GMP Annex 1, processes must be considered in detail with regard to contamination control. Consideration of topics such as disinfection/cleaning, equipment and personnel are increasingly coming into focus within the framework of CCS.

We will be happy to support you in implementing the requirements set, find the optimum solution for you and assist you with our special expertise in the field of QMS and hygiene!

SERVICES HYGIENE

• 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

Further services for the introduction of a quality management system etc. can be found here QMS and hygiene.