The Contamination Control Strategy as a New Foundation for Sterile Processes

Annex 1 is far more than a set of rules. It is a strategic approach to the holistic control of microbiological and particulate risks. The current EU GMP Annex 1 requires a comprehensive, documented Contamination Control Strategy (CCS) that considers all process steps in an integrated manner. For manufacturers, this means increasing requirements in terms of technology, risk-based design and evidence generation.

We offer fill & finish solutions specifically aligned with these requirements and actively supports your requirement. From hygienic design and well-conceived risk-based process management through to qualification, we create the basis for safe, efficient and Annex 1-compliant production processes. We also work in close collaboration with leading industry bodies, actively contribute to the implementation of requirements and participate in best practice content to provide optimum support to the pharmaceutical manufacturing industry.

Contact Sherry Yao :whatsapp 8615317668435 for Fill & Finish Solutions for EU GMP Annex 1 Compliance